DeviceClearance

Product code QUV— Radiology

BioXmark

Classification name
Phase-Changing Fiducial Marker For Radiation Therapy
Device class
Class 2
Regulation
21 CFR 892.5727
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QUV under 21 CFR 892.5727, via openFDA

Market context for product code QUV

FDA has cleared 1 device under product code QUV, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QUV

Recent clearances under product code QUV

Data sourced from openFDA. This site is unofficial and independent of the FDA.