FDA product code QCR: Wound Autofluorescence Imaging Device
QCR is the FDA product code for wound autofluorescence imaging device. It is a Class I device, regulated under 21 CFR 878.4165 and reviewed by the General and Plastic Surgery panel. Devices under QCR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.
Classification
| Field | Value |
|---|---|
| Device name | Wound Autofluorescence Imaging Device |
| Device class | Class I |
| Regulation | 21 CFR 878.4165 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for QCR devices
openFDA lists no recalls for product code QCR.
Frequently asked questions
What is FDA product code QCR?
QCR is the FDA product code for wound autofluorescence imaging device. It is a Class I device, regulated under 21 CFR 878.4165 and reviewed by the General and Plastic Surgery panel.
What device class is QCR?
Class I, regulation 21 CFR 878.4165. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QCR
- Run a recall and safety report across every QCR manufacturer
- Watch product code QCR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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