Phase-Changing Fiducial Marker For Radiation Therapy
The Phase-Changing Fiducial Marker for Radiation Therapy is a single-use, sterile liquid material that is injected into tissue and changes phase in situ to form a solid marker, used to define and track target tissue locations for radiation therapy guidance, visualizable using one or more radiologic imaging modalities. Classified as FDA Class 2 under regulation 892.5727, it requires 510(k) clearance in the Radiology specialty and is flagged as an implant because the solidified marker remains in tissue. It is not life-sustaining.
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Basic Information
- Product Code
- QUV
- Device Class
- FDA class 2
- Regulation Number
- 892.5727
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220017 | BioXmark | Dec 23, 2022 | Unknown | Nanovi A/S |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.