Not Cleared Direct

DEN220017 - BioXmark (FDA 510(k) Clearance)

Class II Radiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220017 · Nanovi A/S · Radiology device
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Dec 2022
Decision
294d
Days
Class 2
Risk

DEN220017 is an FDA 510(k) submission (not cleared) for the BioXmark. Classified as Phase-changing Fiducial Marker For Radiation Therapy (product code QUV), Class II - Special Controls.

Submitted by Nanovi A/S (Kgs. Lyngby, DK). The FDA issued a Not Cleared (DENG) decision on December 23, 2022 after a review of 294 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5727 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 294 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN220017 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 04, 2022
Decision Date December 23, 2022
Days to Decision 294 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 107d · This submission: 294d
Pathway characteristics

Device Classification

Product Code QUV Phase-changing Fiducial Marker For Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5727
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.