510(k) DEN220017
DEN220017 is an FDA 510(k) premarket notification submitted by Nanovi A/S for the device "BioXmark". The FDA issued a decision of De Novo Granted on December 23, 2022. The device falls under product code QUV (Phase-Changing Fiducial Marker For Radiation Therapy), a Class II device regulated under 21 CFR 892.5727.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 23, 2022
- Date Received
- March 4, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phase-Changing Fiducial Marker For Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5727
- Review Panel
- RA
- Submission Type
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.