FDA product code QUV: Phase-Changing Fiducial Marker For Radiation Therapy
QUV is the FDA product code for phase-changing fiducial marker for radiation therapy. It is a Class II device, regulated under 21 CFR 892.5727 and reviewed by the Radiology panel. Devices under QUV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A phase-changing fiducial marker for radiation therapy is a single-use, sterile liquid material that changes phase in situ when injected in tissue for the purposes of aiding radiation therapy treatment. The device is intended to be visualized using one or more radiologic imaging modalities.
Classification
| Field | Value |
|---|---|
| Device name | Phase-Changing Fiducial Marker For Radiation Therapy |
| Device class | Class II |
| Regulation | 21 CFR 892.5727 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for QUV devices
openFDA lists no recalls for product code QUV.
Frequently asked questions
What is FDA product code QUV?
QUV is the FDA product code for phase-changing fiducial marker for radiation therapy. It is a Class II device, regulated under 21 CFR 892.5727 and reviewed by the Radiology panel.
What device class is QUV?
Class II, regulation 21 CFR 892.5727. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QUV
- Run a recall and safety report across every QUV manufacturer
- Watch product code QUV 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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