QUVClass II
Phase-Changing Fiducial Marker For Radiation Therapy
21 CFR 892.5727 / Radiology
QUV is the FDA product code for Phase-Changing Fiducial Marker For Radiation Therapy, a class II device type, regulated under 21 CFR 892.5727. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QUV
- Device name
- Phase-Changing Fiducial Marker For Radiation Therapy
- 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.
- Regulation
- 21 CFR 892.5727
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QUV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2022 | 1 |
Applicants with the most clearances
Product code QUV| Applicant | Clearances |
|---|---|
| Nanovi A/S | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.