QUV · Class II · 21 CFR 892.5727

FDA Product Code QUV: Phase-changing Fiducial Marker For Radiation Therapy

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.

Leading manufacturers include Nanovi A/S.

1
Total
0
Cleared
294d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Phase-changing Fiducial Marker For Radiation Therapy Devices (Product Code QUV)

1 devices
1–1 of 1
Not Cleared Dec 23, 2022
BioXmark
DEN220017
Nanovi A/S
Radiology · 294d

About Product Code QUV - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QUV since 2022, with 0 receiving FDA clearance (average review time: 294 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QUV devices are reviewed by the Radiology panel. Browse all Radiology devices →