RevMed

IB Lab GmbH V2.05 KOALA

Company Name
IB Lab GmbH
Catalog Number
V2.05

Description

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.
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Additional Details

Device Identifier
09120105730037
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
No
Is Single Use
No

Barcode Mapping

Unit of MeasurementEachesGTIN
Each109120105730037
Each109120105730082