KOALA

GUDID 09120105730082

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

X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software

• Primary Device ID: 09120105730082
• NIH Device Record Key: ef1cba2b-6d3c-4ad3-b2fd-66d2cc618010
• Commercial Distribution Discontinuation: 2022-10-27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOALA
• Version Model Number: V2.05
• Company DUNS: 300512152
• Company Name: IB Lab GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com
• Phone: +15616284670
• Email: support@imagebiopsy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120105730037 [Primary]
GS1	09120105730082 [Package]; Contains: 09120105730037; Package: ZOO [1 Units]; Discontinued: 2022-10-27; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192109

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-05-10
• Device Publish Date: 2020-11-03

On-Brand Devices [KOALA]

• 09120105730082: The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the
• 09120105730471: The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the