QUV — Phase-Changing Fiducial Marker For Radiation Therapy Class II
FDA product code QUV covers "Phase-Changing Fiducial Marker For Radiation Therapy", a Class II medical device regulated under 21 CFR 892.5727. Submissions are reviewed by the Radiology panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QUV
- Device Class
- Class II
- Regulation Number
- 892.5727
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220017 | nanovi | BioXmark | December 23, 2022 |