Other products from "SECTRA AB"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
2 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
3 07350092810425 3.2 For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor. QKQ Digital Pathology Image Viewing And Management Software 2 Sectra Digital Pathology Module
4 07350092810241 2.3 For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor. QKQ Digital Pathology Image Viewing And Management Software 2 Sectra Digital Pathology Module
5 07350092810388 3.1 For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor. QKQ Digital Pathology Image Viewing And Management Software 2 Sectra Digital Pathology Module
6 07350092810289 2.4 For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor. QKQ Digital Pathology Image Viewing And Management Software 2 Sectra Digital Pathology Module
7 07350092810197 2.2 For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor. QKQ Digital Pathology Image Viewing And Management Software 2 Sectra Digital Pathology Module
8 07350092810333 2.5 For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor. QKQ Digital Pathology Image Viewing And Management Software 2 Sectra Digital Pathology Module
9 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
10 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
11 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
12 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
13 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
14 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
15 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
16 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
17 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. LLZ System, Image Processing, Radiological 2 Sectra Orthopedic Package
18 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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
19 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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
20 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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
21 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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
24 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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
25 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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
26 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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
27 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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
28 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. LLZ System, Image Processing, Radiological 2 Sectra Workstation
29 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). LLZ System, Image Processing, Radiological 2 Sectra Workstation
30 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). LLZ System, Image Processing, Radiological 2 Sectra Workstation
31 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). LLZ System, Image Processing, Radiological 2 Sectra Workstation
32 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). LLZ System, Image Processing, Radiological 2 Sectra Workstation
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11 M722XD21224B212210 4.0.0 ClearRead Bone Suppress Docker ClearRead Bone Suppress Docker RIVERAIN TECHNOLOGIES, INC.
12 M722XD21165T211640 4.0.0 ClearRead Compare Docker ClearRead Compare Docker RIVERAIN TECHNOLOGIES, INC.
13 M722XD21165L211640 3.0.0 ClearRead Confirm Docker ClearRead Confirm Docker RIVERAIN TECHNOLOGIES, INC.
14 M722XD21165E211640 3.0.0 ClearRead Enhance Docker ClearRead Enhance Docker RIVERAIN TECHNOLOGIES, INC.
15 M722XD21165B211640 4.0.0 ClearRead Bone Suppress Docker ClearRead Bone Suppress Docker RIVERAIN TECHNOLOGIES, INC.
16 M722XD21012T203200 3.0.0 ClearRead Compare on Docker Platform ClearRead Compare Docker RIVERAIN TECHNOLOGIES, INC.
17 M722XD21012L203200 3.0.0 ClearRead Confirm on Docker Platform ClearRead Confirm Docker RIVERAIN TECHNOLOGIES, INC.
18 M722XD21012E203200 3.0.0 ClearRead Enhanced on Docker Platform ClearRead Enhanced Docker RIVERAIN TECHNOLOGIES, INC.
19 M722XD21012B203200 3.0.0 ClearRead Bone Suppress on Docker Platform ClearRead Bone Suppress Docker RIVERAIN TECHNOLOGIES, INC.
20 M722XD20239T200370 1.2.0 ClearRead Compare on Docker Platform ClearRead Compare Docker RIVERAIN TECHNOLOGIES, INC.
21 M722XD20239L200370 1.2.0 ClearRead Confirm on Docker Platform ClearRead Confirm Docker RIVERAIN TECHNOLOGIES, INC.
22 M722XD20239E200370 1.2.0 ClearRead Enhanced on Docker Platform ClearRead Enhanced Docker RIVERAIN TECHNOLOGIES, INC.
23 M722XD20239B200370 1.2.0 ClearRead Bone Suppress on Docker Platform ClearRead Bone Suppress Docker RIVERAIN TECHNOLOGIES, INC.
24 M722XD20104T20370 3.3.1 ClearRead Compare on Docker Platform.Primary DI Number should be M722XD20104T200 ClearRead Compare on Docker Platform.Primary DI Number should be M722XD20104T200370.Re-entered on 12/30/2020. ClearRead Compare Docker RIVERAIN TECHNOLOGIES, INC.
25 M722XD20104T200370 1.1.0 ClearRead Compare on Docker Platform.Primary DI Number mistyped as M722XD20104T2 ClearRead Compare on Docker Platform.Primary DI Number mistyped as M722XD20104T20370.Originally entered on 5/19/2020. ClearRead Compare Docker RIVERAIN TECHNOLOGIES, INC.
26 M722XD20104L20370 2.2.1 ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L2003 ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L200370.Re-entered on 12/30/2020. ClearRead Confirm Docker RIVERAIN TECHNOLOGIES, INC.
27 M722XD20104L200370 1.1.0 ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Ori ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Originally entered on 5/19/2020. ClearRead Confirm Docker RIVERAIN TECHNOLOGIES, INC.
28 M722XD20104E20370 2.2.1 ClearRead Enhanced on Docker Platform.Primary DI Number should be M722XD20104E20 ClearRead Enhanced on Docker Platform.Primary DI Number should be M722XD20104E200370.Re-entered 12/30/2020. ClearRead Enhanced Docker RIVERAIN TECHNOLOGIES, INC.
29 M722XD20104E200370 1.1.0 ClearRead Enhanced on Docker Platform.Primary DI Number mistype as M722XD20104E2 ClearRead Enhanced on Docker Platform.Primary DI Number mistype as M722XD20104E20370.Original submission date 5/19/2020. ClearRead Enhanced Docker RIVERAIN TECHNOLOGIES, INC.
30 M722XD20104B20370 3.6.2 ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD201 ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD20104B200370.Re-entered 12/30/2020. ClearRead Bone Suppress Docker RIVERAIN TECHNOLOGIES, INC.
31 M722XD20104B200370 1.1.0 ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD2 ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD20104B20370.Originally entered on 5/19/2020 ClearRead Bone Suppress Docker RIVERAIN TECHNOLOGIES, INC.
32 M722XC22145T212210 4.0.0 ClearRead Compare on Console Platform ClearRead Xray Compare RIVERAIN TECHNOLOGIES, INC.
33 M722XC22145L212210 3.0.0 ClearRead Confirm on Console Platform ClearRead Xray Confirm RIVERAIN TECHNOLOGIES, INC.
34 M722XC22145E212210 3.0.0 ClearRead Enhance on Console Platform ClearRead Xray Enhance RIVERAIN TECHNOLOGIES, INC.
35 M722XC22145B212210 4.0.0 ClearRead Bone Suppress on Console Platform ClearRead Xray Bone Suppress RIVERAIN TECHNOLOGIES, INC.
36 M722XC21224T212210 4.0.0 ClearRead Compare Console ClearRead Compare Console RIVERAIN TECHNOLOGIES, INC.
37 M722XC21224L212210 3.0.0 ClearRead Confirm Console ClearRead Confirm Console RIVERAIN TECHNOLOGIES, INC.
38 M722XC21224E212210 3.0.0 ClearRead Enhance Console ClearRead Enhance Console RIVERAIN TECHNOLOGIES, INC.
39 M722XC21224B212210 4.0.0 ClearRead Bone Suppress Console ClearRead Bone Suppress Console RIVERAIN TECHNOLOGIES, INC.
40 M722XC21165T211640 4.0.0 ClearRead Compare Console ClearRead Compare Console RIVERAIN TECHNOLOGIES, INC.
41 M722XC21165L211640 3.0.0 ClearRead Confirm Console ClearRead Confirm Console RIVERAIN TECHNOLOGIES, INC.
42 M722XC21165E211640 3.0.0 ClearRead Enhance Console ClearRead Enhance Console RIVERAIN TECHNOLOGIES, INC.
43 M722XC21165B211640 4.0.0 ClearRead Bone Suppress Console ClearRead Bone Suppress Console RIVERAIN TECHNOLOGIES, INC.
44 M722X22145T212210 4.0.0 ClearRead Compare on Server Platform ClearRead Xray Compare RIVERAIN TECHNOLOGIES, INC.
45 M722X22145L212210 3.0.0 ClearRead Confirm on Server Platform ClearRead Xray Confirm RIVERAIN TECHNOLOGIES, INC.
46 M722X22145E212210 3.0.0 ClearRead Enhance on Server Platform ClearRead Xray Enhance RIVERAIN TECHNOLOGIES, INC.
47 M722X22145B212210 4.0.0 ClearRead Bone Suppress on Server Platform ClearRead Xray Bone Suppress RIVERAIN TECHNOLOGIES, INC.
48 M722X21224T212210 4.0.0 ClearRead Compare on Server ClearRead Compare Server RIVERAIN TECHNOLOGIES, INC.
49 M722X21224L212210 3.0.0 ClearRead Confirm on Server ClearRead Confirm Server RIVERAIN TECHNOLOGIES, INC.
50 M722X21224E212210 3.0.0 ClearRead Enhance on Server ClearRead Enhance Server RIVERAIN TECHNOLOGIES, INC.