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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
V2.05
Not in Commercial Distribution
- 09120105730082 ()
- 09120105730037 ()
- X-ray image interpretive software
Quantum Warm XL LED Surgical Headlight
Enova Illumination, Inc.
5460-700-046
In Commercial Distribution
- 00850025993791 ()
- Head-worn lamp
Quantum Cool XL LED Surgical Headlight
Enova Illumination, Inc.
5460-700-045
In Commercial Distribution
- 00850025993784 ()
- Head-worn lamp
Quantum Deluxe Comfort Pad Set - 10 Pack
Enova Illumination, Inc.
5460-700-040
In Commercial Distribution
- 00850025993241 ()
5460-700-040
- Head-worn lamp
Quantum Deluxe Comfort Pad Set - 3 Pack
Enova Illumination, Inc.
5460-700-038
In Commercial Distribution
- 00850025993227 ()
5460-700-038
- Head-worn lamp
Quantum Warm LED Surgical Headlight
Enova Illumination, Inc.
5460-700-012
In Commercial Distribution
- 00850025993203 ()
5460-700-012
- Head-worn lamp
Quantum Cool LED Surgical Headlight
Enova Illumination, Inc.
5460-700-011
In Commercial Distribution
- 00850025993173 ()
5460-700-011
- Head-worn lamp
Quantum Occipital Comfort Pad
Enova Illumination, Inc.
5460-700-026
In Commercial Distribution
- 00850025993111 ()
5460-700-026
- Head-worn lamp
Quantum Deluxe Comfort Pad Set
Enova Illumination, Inc.
5460-700-027
In Commercial Distribution
- 00850025993081 ()
5460-700-027
- Head-worn lamp
Quantum Occipital Mesh Replacement
Enova Illumination, Inc.
5460-700-030
In Commercial Distribution
- 00850025993074 ()
5460-700-030
- Head-worn lamp