Other products from "KONICA MINOLTA MEDICAL IMAGING U.S.A., INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00817100020490 OPAL 02-04-06-000 Opal-RAD is a software device that receives digital images and data from various Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. KPR System, X-Ray, Stationary 2 Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad
2 00817100020391 CRII60 CR Reader-R MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 CR Reader
3 00817100020360 CR30 AF CR Reader-R MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 CR Reader
4 00817100020247 PAN241 IR 14X17 Portable GOS Flat Panel Detector without USB (-R or -L) MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 14X17 Portable GOS Flat Panel Detector without USB
5 00817100020209 OPAL 02-04-04-000 Opal-RAD is a software device that receives digital images and data from various Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. KPR System, X-Ray, Stationary 2 Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad
6 00817100020148 XR410i PXS-710 X-Ray System, Podiatry DR Ready (70kVp,10mA). KPR,MQB System, X-Ray, Stationary,Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 2020 Imaging Podiatry System HF
7 00817100020032 XR3000 Universal U-arm system - With Motorized Auto Positioning and Touchscreen control KPR System, X-Ray, Stationary 2 U-Arm System
8 00817100020452 PAN253 17X17 flat Panel Detector (CsI) MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 1717 Flat Panel Detector
9 00817100020445 PAN252 17X17 Flat Panel Detector (GOS) MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 1717 Flat Panel Detector
10 00817100020414 OPALACQ-04-01-00-000 Software, Opal Acquire Image Acquisition Software. LLZ System, Image Processing, Radiological 2 Konica Minolta SW Opal (Acquire), 20/20 Opal (Acquire)
11 00817100020315 PAN290 RF 14X17 Sensor Panel-R MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 RF 14X17 Sensor Panel
12 00817100020049 XR3002 Advanced Universal U-arm Stand 3000 - 8' Motorized Auto Positioning and Touchs Advanced Universal U-arm Stand 3000 - 8' Motorized Auto Positioning and Touchscreen control KPR System, X-Ray, Stationary 2 Advanced Universal U-Arm Stand 3000
13 00817100020094 XR5200 NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touc NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touch screen panel (to work with auto position table and wall stand versions). KPR System, X-Ray, Stationary 2 Overhead Tube Crane
14 00817100020070 XR5100 Manual ceiling suspension tube stand ONLY KPR System, X-Ray, Stationary 2 Overhead Tube Crane Ceiling Suspension
15 00817100020469 CASCR2430 10X12 Cassette for CR Reader - R MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 10X12 Cassette for CR Reader
16 00817100020223 PAN221 IR 17X17 GOS Fixed Flat Panel Detector (-R or -L) MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 17X17 GOS Fixed Flat Panel Detector
17 00817100020162 XR1000i 2020SA 2020i Radiographic Straight Arm system variable focal distance left loading only KPR System, X-Ray, Stationary 2 2020i Straight Arm
18 00817100020100 RF6000 Platinum Radiographic / Fluoroscopic system 90/90 DRF43 FL with generator and X-Ray tube. JAA System, X-Ray, Fluoroscopic, Image-Intensified 2 Dynamic DR Room
19 00817100020063 XR100 Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Digital SID KPR System, X-Ray, Stationary 2 Millenium Floor Mounted Tube Stand
20 00817100020056 XR3500B Advanced Universal U-arm Stand 4000 - Motorized Auto Positioning and Touchscreen control KPR System, X-Ray, Stationary 2 Advanced Universal U-Arm Stand 4000
21 00817100020025 XR3001 Universal U-arm system - Motorized. KPR System, X-Ray, Stationary 2 U-Arm System Basic
22 00817100020407 ULTRA 04-01-00-000 ViZion Ultra is intended for digital image capture use in general radiographic e ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 Konica Minolta Ultra Software
23 00817100020308 PAN261 THL 4143C CsI High Resolution Digital Flat Panel Detector-R MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 4143C CsI Compact Digital Flat Panel Detector
24 00817100020018 XR1000 Universal Radiographic Straight Arm system variable focal distance left loading Only. KPR System, X-Ray, Stationary 2 Straight Arm System
25 00817100020476 CASCR3543 CRF-CASSETTE-35X43-R MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 14X17 Cassette for CR Reader
26 00817100020438 OPALACQ-02-04-00-000 Software, Opal Acquire Image Acquisition Software. LLZ System, Image Processing, Radiological 2 Konica Minolta Software Opal Acquire
27 00817100020322 PAN251 SMS 14X17 Flat Panel Detector-R MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 14X17 Flat Panel Detector
28 00817100020285 PAN280 THL 3543EZ CsI Digital Wireless Flat Panel Detector-R MQB,KPR Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Stationary 2 3543EZ CsI Digital Wireless Flat Panel Detector
29 00817100020230 PAN240 IR 14X17 Portable GOS Flat Panel Detector (-R or -L) MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 14X17 Portable GOS Flat Panel Detector
30 00817100020216 PAN220 IR 17X17 CsI Fixed Flat Panel Detector (-R or -L) MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 17X17 CsI Fixed Flat Panel Detector
31 00817100020186 OPALACQ 04-02-01-000 Software, Opal Acquire Image Acquisition Software. LLZ System, Image Processing, Radiological 2 Konica Minolta SW (Acquire) Opal, 20/20 Opal (Acquire) Vizion
32 00817100020155 XR420i HDR Dedicated Hand X-Ray system KPR System, X-Ray, Stationary 2 2020i Imaging Hand System
33 00817100020353 XR301 Portable X-Ray System-R IZL System, X-Ray, Mobile 2 Portable X-Ray System
34 00817100020339 PAN262 THL Flat Panel Detector-R KPR System, X-Ray, Stationary 2 Flat Panel Detector
35 00817100020261 PAN260 THL 4343 CsI Digital Flat Panel Detector-R MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 4343 CsI Digital Flat Panel Detector
36 00817100020131 XR400i BD715 20/20 BiDirectional PDR X-ray Machine. KPR System, X-Ray, Stationary 2 2020 Imaging Podiatry System
37 00817100020124 XR310 SR-130 + DR Portable VIZION M portavle X-Ray System (100kV/30mA). IZL System, X-Ray, Mobile 2 Portable X-Ray System
38 00817100020117 XR300 SR-130 + DR Portable X-Ray System (100kV/30mA). IZL System, X-Ray, Mobile 2 Portable X-Ray System
39 00817100020254 PAN200 IR 14X17 Wireless GOS Flat Panel Detector -R or -L) MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 14X17 Wireless GOS Flat Panel Detector
40 00817100020193 EXA 01-04-000 EXA is a software device that receives digital images and data from various sour EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.Lossy compressed mammographic images are not intended for diagnostic review. LLZ System, Image Processing, Radiological 2 Konica Minolta SW (PACS) Exa
41 00817100020513 PAN292 DR-PANEL-LT1114-L / R MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 RF 11X14 Sensor Panel
42 00817100020483 PAN291 RF 11X14 Sensor Panel -R/-L MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 RF 11X14 Sensor Panel
43 00817100020179 ULTRA 04-02-01-000 ViZion Ultra is intended for digital image capture use in general radiographic e ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) 2 Konica Minolta SW (Acquire) Ultra
Other products with the same Product Code "LLZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 07540263000025 3.0 The VMS+ system is an adjunct to existing ultrasound imaging systems and is inte The VMS+ system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS+ system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired. Ventripoint Medical System Plus (VMS+) VENTRIPOINT DIAGNOSTICS LTD
2 07392532209413 Version 3.1 54500395IV31 Case Viewer Simplant DENTSPLY IMPLANTS NV
3 07392532208423 Version 3.1 54500394E31 Simplant Editor Simplant DENTSPLY IMPLANTS NV
4 07392532208416 Version 18.5 54500277V185 Simplant View Simplant DENTSPLY IMPLANTS NV
5 07392532206269 Version 18.5 54500277P185 Simplant Pro Simplant DENTSPLY IMPLANTS NV
6 07392532205583 Version 3 54500395IV3 Case Viewer Simplant DENTSPLY IMPLANTS NV
7 07392532204814 Version 3 54500394E3 Simplant Editor Simplant DENTSPLY IMPLANTS NV
8 07392532191251 Version 18 54500277P18 Simplant Pro Simplant DENTSPLY IMPLANTS NV
9 07392532191237 Version 18 54500277O18 Simplant OneShot Simplant DENTSPLY IH, INC.
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11 07392532181276 Version 2 54500395IV SIMPLANT Viewer SIMPLANT® DENTSPLY IMPLANTS NV
12 07392532181252 Version 2 54500394E2 SIMPLANT Editor SIMPLANT® DENTSPLY IMPLANTS NV
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14 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
15 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
16 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
17 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
18 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
19 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
20 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
21 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
22 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
23 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
24 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
25 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
26 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
27 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
28 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
29 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
30 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
31 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
32 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
33 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
34 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
35 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
36 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
37 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
38 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
39 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
40 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
41 07350010100027 2 Software for cardiac image analysis. Segment CMR MEDVISO AB
42 07350010100010 2 Software for medical image analysis. Segment MEDVISO AB
43 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
44 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
45 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
46 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
47 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
48 07340201500040 AATMA AATMA ELEKTA SOLUTIONS AB
49 07332747199802 3.2_L 300851 DTX Studio Clinic 3.2 for Win 64-bit limited DTX Studio™ Clinic NOBEL BIOCARE AB
50 07332747199796 3.2_L 300851 DTX Studio Clinic 3.2 for Mac limited DTX Studio™ Clinic NOBEL BIOCARE AB