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FDA-cleared K223646

IB Lab LAMA

IB Lab GmbH

Authorized purpose: Automatically measures limb-length discrepancy and quantitative knee-alignment parameters on AP full-leg radiographs.

Modality
X-ray/Radiography
Anatomy
Lower limb/full leg and knee alignment
Decision
2023-06-16
FDA-cleared K192109

KOALA

IB Lab GmbH

Authorized purpose: 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 PA/AP knee X-ray images.

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2019-11-05