QUV · Phase-Changing Fiducial Marker For Radiation Therapy
Radiology · 21 CFR 892.5727 · Class 2
Overview
| Product Code | QUV |
|---|---|
| Device Name | Phase-Changing Fiducial Marker For Radiation Therapy |
| Regulation | 21 CFR 892.5727 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| Implant | Yes |
Identification
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. BioXmark is indicated for use to radiographically mark lung, bladder and lymph nodes in adult patients for whom it has been determined that radiographical marking of tissue for radiation treatment is indicated for their cancer treatment.
Classification Rationale
Class II (special controls). The device is granted under the De Novo process, and the probable benefits outweigh the probable risks, which can be mitigated by the use of general controls and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the Phase-changing fiducial marker for radiation therapy is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220017 | BioXmark | Nanovi A/S | Dec 23, 2022 | DENG |
Top Applicants
- Nanovi A/S — 1 clearance
