FDA product code QNK: Optoacoustic Imaging System
QNK is the FDA product code for optoacoustic imaging system. It is a Class III device, reviewed by the Radiology panel. Devices under QNK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis
Classification
| Field | Value |
|---|---|
| Device name | Optoacoustic Imaging System |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QNK devices
openFDA lists no recalls for product code QNK.
Frequently asked questions
What is FDA product code QNK?
QNK is the FDA product code for optoacoustic imaging system. It is a Class III device, reviewed by the Radiology panel.
What device class is QNK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QNK
- Run a recall and safety report across every QNK manufacturer
- Watch product code QNK 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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