meddevicedb.com FDA Device Reference

BioXmark

DEN220017 Class II Direct
Decision Date
2022-12-23
Sponsor / Applicant
Nanovi A/S

Technical Specification

510(k) Submission ID DEN220017
Product Code QUV
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.5727
Decision Date 2022-12-23
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

BioXmark received FDA 510(k) clearance under submission number DEN220017, sponsored by Nanovi A/S. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-12-23.

Classification & Regulation

This clearance is catalogued under FDA product code QUV and 21 CFR 892.5727, within the Radiology review panel as a Class II device.