KOALA - The Knee OsteoArthritis Labeling Assistant - IB Lab GmbH

Duns Number:300512152

Device Description: The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements o 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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More Product Details

Catalog Number

-

Brand Name

KOALA

Version/Model Number

V2.11

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 23, 2023

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192109,K192109

Product Code Details

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Device Record Status

Public Device Record Key

74beecb9-aac7-4c85-8a59-864c335f5a56

Public Version Date

January 19, 2022

Public Version Number

1

DI Record Publish Date

January 11, 2022

Additional Identifiers

Package DI Number

09120105730471

Quantity per Package

1

Contains DI Package

09120105730464

Package Discontinue Date

December 23, 2023

Package Status

In Commercial Distribution

Package Type

ZOO

"IB LAB GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2