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The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.11
Not in Commercial Distribution
- 09120105730471 ()
- 09120105730464 ()
- X-ray image interpretive software
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.05
Not in Commercial Distribution
- 09120105730082 ()
- 09120105730037 ()
- X-ray image interpretive software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution
- 03770021392114 ()
2001-001
- Patient self-taken medical image communication software
- Clinical management support software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution
- 03760405340251 ()
2001-001
- Patient self-taken medical image communication software
- Clinical management support software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution
- 03760405340244 ()
2001-001
- Patient self-taken medical image communication software
- Clinical management support software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution
- 03760405340237 ()
2001-001
- Patient self-taken medical image communication software
- Clinical management support software
Applications Platform 4.0 INTL – INT KIT – 3 Room
IMRIS Imaging, Inc.
120088-000
In Commercial Distribution
- 00857534006684 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 INTL – INT KIT
IMRIS Imaging, Inc.
120086-000
In Commercial Distribution
- 00857534006677 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 INTL – 3 Room
IMRIS Imaging, Inc.
119898-000
In Commercial Distribution
- 00857534006660 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0-INTL-2-Room
IMRIS Imaging, Inc.
119408-000
In Commercial Distribution
- 00857534006653 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000
IMRIS Imaging, Inc.
Application Platform 4.0 KIT
In Commercial Distribution
- 00857534006646 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – INT KIT-120085-000
IMRIS Imaging, Inc.
Application Platform 4.0- KIT
In Commercial Distribution
- 00857534006639 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – 3 Room- 119897-000
IMRIS Imaging, Inc.
Application Platform 4.0- 3 Room
In Commercial Distribution
- 00857534006622 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000
IMRIS Imaging, Inc.
Application Platform 4.0 2-Room
In Commercial Distribution
- 00857534006493 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Application Platform 2.4 NA
IMRIS Imaging, Inc.
115407-000
In Commercial Distribution
- 00857534006363 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
No Description
Circle Cardiovascular Imaging Inc
6.x
In Commercial Distribution
- 00882916000028 ()
- MRI system application software
- CT system application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- HL7 Integration Engine
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NHL7
In Commercial Distribution
- 07290110252595 ()
HASP-SW-K-NHL7IE-01
- Medical equipment clinical data interfacing software
ExamVue PACS version 1.1 Build 81
TELEVERE SYSTEMS, LLC
1.1 Build 81
In Commercial Distribution
- 00851800007078 ()
ExamVue PACS 1.1 Build 81
- Radiological PACS software
- General-purpose dental x-ray system application software
- Multidisciplinary medical image management software
- Camera application software
- Basic diagnostic x-ray system application software
For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit and display images as a PACS application. In addition it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files
Radiology Information Systems, Inc.
RSVS
In Commercial Distribution
- 00860009490642 ()
- Radiological PACS software
- Radiology picture archiving and communication system digital archive device
Local Hyperthermia System (U.S.A.)
BSD MEDICAL CORPORATION
BSD-500
Not in Commercial Distribution
- 00851551005194 ()
- Microwave hyperthermia system