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BioTraceIO Lite

DEN230020 Class II Direct
Decision Date
2023-12-22
Sponsor / Applicant
Techsomed Medical Technologies , Ltd.

Technical Specification

510(k) Submission ID DEN230020
Product Code QZL
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2052
Decision Date 2023-12-22
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

BioTraceIO Lite received FDA 510(k) clearance under submission number DEN230020, sponsored by Techsomed Medical Technologies , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-12-22.

Classification & Regulation

This clearance is catalogued under FDA product code QZL and 21 CFR 892.2052, within the Radiology review panel as a Class II device.