510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220017Unknown

BioXmark

Nanovi A/S, Kgs. Lyngby, DK / Direct, Unknown
FDA source (opens on fda.gov)

DEN220017 is the FDA 510(k) clearance record for BioXmark, a class II device, cleared for Nanovi A/S on under FDA product code QUV (Phase-Changing Fiducial Marker For Radiation Therapy). FDA's definition for product code QUV reads: "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...". FDA records list one 510(k) clearance for Nanovi A/S. As of , FDA records show no recalls naming DEN220017.

Clearance record

Decision date
Received
(294 days to decision)
Product code
QUV Phase-Changing Fiducial Marker For Radiation Therapy
Regulation
21 CFR 892.5727
Device class
Class II
Review panel
Radiology
Applicant
Nanovi A/S Diplomvej 378, Kgs. Lyngby, DK
Third party review
No

Clearances, product code QUV

Trailing 12 months

FDA records hold no clearances under product code QUV in the trailing twelve months.

FDA records show no clearances under product code QUV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QUV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260