Other products from "SAMSUNG MEDISON CO., LTD."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 08806167752071 USP-PF38F0A/WR ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 Transducer PA3-8B
2 08806167702953 USS-SAR5N30/US IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
3 08809880020595 USS-RS85G4P/US IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 RS85
4 08809880020434 USS-RS85G4I/US IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 RS85
5 08809880020380 USS-RS85F4P/US IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 RS85
6 08809880020229 USS-RS85F4I/US IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 RS85
7 08809725796869 USS-HRW1Q4C/US HERA W10 V1.02 IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 HERA W10 Diagnostic Ultrasound System
8 08809725796340 USS-HRW1F4C/US HERA W10 V1.02 IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 HERA W10 Diagnostic Ultrasound System
9 08809521028836 USP-L04IF3A/WR LA4-18A Transducer IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 LA4-18A
10 08806167759643 USO-UW85A0K/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 5D ADV PACKAGE
11 08806167751197 USO-YR7ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
12 08806167751142 USO-YV5ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
13 08806167751111 USO-YR5ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
14 08806167751081 USO-YV3ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
15 08806167751050 USO-YR3ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
16 08806167750893 USO-YA3BNN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
17 08806167750886 USO-YA3ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
18 08806167750756 USO-YV6ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
19 08806167750732 USO-YU6ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
20 08806167750664 USO-YH7ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
21 08806167750633 USO-YP6ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
22 08806167750558 USO-YW8ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
23 08806167750503 USO-YR8ANN0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ACCESSORY SET
24 08806167748432 USO-UW85H00/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 5D HEART
25 08806167746728 USO-UR8EA00/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ECG-AHA
26 08806167799137 USS-HRW1F40/US ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 HERA W10 Diagnostic Ultrasound System
27 08806167799045 USS-HRW1F40/WW ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 HERA W10 Diagnostic Ultrasound System
28 08806167799038 USS-HRW1F40/WR ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 HERA W10 Diagnostic Ultrasound System
29 08806167741631 USO-UG6EAD0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ECG/AHAINTHESYS
30 08806167741624 USO-UG6EA00/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ECG/AHA
31 08806167740931 USS-EKO7N3C/WW ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 EKO7 Diagnostic Ultrasound System
32 08806167740696 USP-PZ24DAA/WR ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 Transducer P2-4BA
33 08806167740085 USP-CN49E0A/WR ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 Transducer CN4-9
34 08806167739720 USP-LN5CE4B/WR ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 Transducer LN5-12/40
35 08806167739584 USP-P038F0A/WR ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 Transducer SP3-8
36 08806167739560 USP-P038ESA/WR ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 Transducer SP3-8
37 08806167731748 USO-UG6EID0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 ECG/IECINTHESYS
38 08806167727628 USO-UG6EM00/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 E-MOTION MARKER
39 08806167714147 USP-V048E00/WR ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 Transducer 3D4-8
40 08806167710248 USO-P0NBMI0/WR IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 Mitsubishi P95DE
41 08809725815041 USP-L029NSA/WR ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 LA2-9S
42 08809725794742 USS-HS6FB4N/US IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 HS60 Diagnostic Ultrasound System
43 08809725794568 USS-HS6FN4N/US IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 HS60 Diagnostic Ultrasound System
44 08809725782732 USS-HS6NB4N/US V2.03 IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 HS60 Diagnostic Ultrasound System
45 08809725782350 USS-HS6NL4N/US V2.03 IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 HS60 Diagnostic Ultrasound System
46 08809521027662 USS-HS5NL4M/US ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 HS50 / HS60 Diagnostic Ultrasound System
47 08809521028805 USS-HS5PF3M/US ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 HS50 / HS60 Diagnostic Ultrasound System
48 08809521028614 USS-HS5PB3M/US ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 HS50 / HS60 Diagnostic Ultrasound System
49 08809521028423 USS-HS5NL3M/US ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 HS50 / HS60 Diagnostic Ultrasound System
50 08809521028232 USS-HS5NB3M/US ITX,IYO,IYN Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,Syst Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic 2 HS50 / HS60 Diagnostic Ultrasound System
Other products with the same Product Code "LLZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 07392532209413 Version 3.1 54500395IV31 Case Viewer Simplant DENTSPLY IMPLANTS NV
2 07392532208423 Version 3.1 54500394E31 Simplant Editor Simplant DENTSPLY IMPLANTS NV
3 07392532208416 Version 18.5 54500277V185 Simplant View Simplant DENTSPLY IMPLANTS NV
4 07392532206269 Version 18.5 54500277P185 Simplant Pro Simplant DENTSPLY IMPLANTS NV
5 07392532205583 Version 3 54500395IV3 Case Viewer Simplant DENTSPLY IMPLANTS NV
6 07392532204814 Version 3 54500394E3 Simplant Editor Simplant DENTSPLY IMPLANTS NV
7 07392532191251 Version 18 54500277P18 Simplant Pro Simplant DENTSPLY IMPLANTS NV
8 07392532191237 Version 18 54500277O18 Simplant OneShot Simplant DENTSPLY IH, INC.
9 07392532191220 Version 18 54500277V18 Simplant View Simplant DENTSPLY IMPLANTS NV
10 07392532181276 Version 2 54500395IV SIMPLANT Viewer SIMPLANT® DENTSPLY IMPLANTS NV
11 07392532181252 Version 2 54500394E2 SIMPLANT Editor SIMPLANT® DENTSPLY IMPLANTS NV
12 07392532178030 Version 17 54500277A SIMPLANT Pro SIMPLANT® DENTSPLY IMPLANTS NV
13 07350092810432 16.2 Sectra Orthopaedic Package is intended to assist the user when doing preoperativ Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images.For example the Sectra Orthopaedic Package shall:• Assist the orthopaedic surgeons in choosing which implants to use.• Assist the orthopaedic surgeons in choosing where to place cut lines etc.• Assist the orthopaedic surgeons in following-up of surgical procedures.• Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery.• Assist the radiologist in making MSK measurements.• Assist the user in producing outputs for post-processing such as 3D prints of anatomical models.Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists. Sectra Orthopedic Package SECTRA AB
14 07350092810418 24.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
15 07350092810401 16.1 Sectra Orthopaedic Package is intended to assist the user when doing preoperativ Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images.For example the Sectra Orthopaedic Package shall:• Assist the orthopaedic surgeons in choosing which implants to use.• Assist the orthopaedic surgeons in choosing where to place cut lines etc.• Assist the orthopaedic surgeons in following-up of surgical procedures.• Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery.• Assist the radiologist in making MSK measurements.• Assist the user in producing outputs for post-processing such as 3D prints of anatomical models.Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists. Sectra Orthopedic Package SECTRA AB
16 07350092810371 24.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
17 07350092810364 15.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
18 07350092810357 23.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
19 07350092810326 23.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
20 07350092810296 14.2 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
21 07350092810265 22.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
22 07350092810258 14.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
23 07350092810234 21.3 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
24 07350092810227 12.2 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
25 07350092810210 22.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
26 07350092810180 21.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
27 07350092810173 12.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
28 07350092810166 21.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
29 07350092810159 20.3 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
30 07350092810111 11.2 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
31 07350092810098 20.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
32 07350092810081 11.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
33 07350092810074 20.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.In the United States only:- Mammographic images must be reviewed on a monitor approved by FDA for mammographic images- The Sectra Workstation is not intended for primary diagnosis of digital pathology images.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast). Sectra Workstation SECTRA AB
34 07350092810067 19.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.In the United States only:- Mammographic images must be reviewed on a monitor approved by FDA for mammographic images- The Sectra Workstation is not intended for primary diagnosis of digital pathology images.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast). Sectra Workstation SECTRA AB
35 07350092810050 19.3 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.In the United States only:- Mammographic images must be reviewed on a monitor approved by FDA for mammographic images- The Sectra Workstation is not intended for primary diagnosis of digital pathology images.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast). Sectra Workstation SECTRA AB
36 07350092810043 10.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
37 07350092810036 19.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.In the United States only:- Mammographic images must be reviewed on a monitor approved by FDA for mammographic images- The Sectra Workstation is not intended for primary diagnosis of digital pathology images.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast). Sectra Workstation SECTRA AB
38 07350092810029 9.2 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
39 07350092810012 18.2 Sectra Workstation is intended for the display and manipulation of medical image Sectra Workstation is intended for the display and manipulation of medical images and other related medical information. It can show images from different sources and interface with various image storage and printing devices using DICOM and similar interface standards.Areas of application include, e.g., radiology, mammography, pathology, orthopedic preoperative planning and postoperative follow-up.Lossy compressed mammographic images are not intended for diagnostic review. For primary diagnosis, post-process DICOM “for presentation” images should be used.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants. Sectra Workstation IDS7 SECTRA AB
40 07350010100027 2 Software for cardiac image analysis. Segment CMR MEDVISO AB
41 07350010100010 2 Software for medical image analysis. Segment MEDVISO AB
42 07350002336021 02 602 PYLARIFY AI is intended to be used by healthcare professionals and researchers f PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis. PYLARIFY AI EXINI DIAGNOSTICS AB
43 07350002336014 01 601 PYLARIFY AI is a software only medical device that provides quantitative assessm PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging, using PSMA PET/CT, within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensity-weighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. PYLARIFY AI EXINI DIAGNOSTICS AB
44 07350002335017 01 501 aPROMISE is a softwareonly medical device that provides quantitative assessments aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensityweighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. aPROMISE EXINI DIAGNOSTICS AB
45 07350002332030 03 203 The aBSI is a software-only medical device that provides a fully quantitative as The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient’s skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results. aBSI EXINI DIAGNOSTICS AB
46 07350002331033 3 103 EXINI is intended to be used by trained health-care professionals and researcher EXINI is intended to be used by trained health-care professionals and researchers for acceptance, transfer,storage, image display, manipulation, quantification and reporting of digital medical images. The system isintended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). Thesoftware provides general Picture Archiving and Communications System (PACS) tools and a clinical applicationfor oncology including lesion marking and analysis. EXINI EXINI DIAGNOSTICS AB
47 07340201500040 AATMA AATMA ELEKTA SOLUTIONS AB
48 07332747199802 3.2_L 300851 DTX Studio Clinic 3.2 for Win 64-bit limited DTX Studio™ Clinic NOBEL BIOCARE AB
49 07332747199796 3.2_L 300851 DTX Studio Clinic 3.2 for Mac limited DTX Studio™ Clinic NOBEL BIOCARE AB
50 07332747197525 2.4 300011 IPS CaseDesigner 2.4 for Windows 64-bit IPS CaseDesigner® NOBEL BIOCARE AB