# Phase-Changing Fiducial Marker For Radiation Therapy
> **Product code: QUV** · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.5727
## Classification
- **FDA Product Code:** QUV
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 892.5727
- **Review panel:** RA
- **Medical specialty:** Radiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QUV)
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