QUV
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Phase-Changing Fiducial Marker For Radiation Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5727
- Medical specialty
- Radiology
- Flags
- Implant
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BioXmark (DEN220017) | Nanovi A/S | 2022-12-23 |
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Every clearance here is in the API, with alerts when new ones post.