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.
Catalog Number
-
Brand Name
KOALA
Version/Model Number
V2.05
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 2022
Issuing Agency
In GS1
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
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
ef1cba2b-6d3c-4ad3-b2fd-66d2cc618010
Public Version Date
October 27, 2022
Public Version Number
3
DI Record Publish Date
November 03, 2020
Package DI Number
09120105730082
Quantity per Package
1
Contains DI Package
09120105730037
Package Discontinue Date
October 27, 2022
Package Status
Not in Commercial Distribution
Package Type
ZOO
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |