IB Lab GmbH

Address:Zehetnergasse 6/2/2,Vienna Wien,AT

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (2) System, X-Ray, Tomography, Computed (JAK) (2)

Premarket Exempt

Clear

KOALA - 09120105730037 Catalog Number :

Device Description : The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas 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.

Device Class : 2

Duns Number: 300512152

Premarket Exempt : No

Product Code : LLZ, JAK

Prescription Use : Yes

Device Count : 1

KOALA - 09120105730464 Catalog Number :