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RefleXion Medical Radiotherapy System (RMRS)

DEN220014 Class II Direct
Decision Date
2023-02-01
Sponsor / Applicant
Reflexion Medical, Inc.

Technical Specification

510(k) Submission ID DEN220014
Product Code QVA
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.5060
Decision Date 2023-02-01
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

RefleXion Medical Radiotherapy System (RMRS) received FDA 510(k) clearance under submission number DEN220014, sponsored by Reflexion Medical, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-02-01.

Classification & Regulation

This clearance is catalogued under FDA product code QVA and 21 CFR 892.5060, within the Radiology review panel as a Class II device.