QUV

Phase-Changing Fiducial Marker For Radiation Therapy

Product code

QUV

Device name

Phase-Changing Fiducial Marker For Radiation Therapy

Device class

Class 2

21 CFR

21 CFR 892.5727

Medical specialty

Radiology

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).