Not Cleared Direct

DEN220014 - RefleXion Medical Radiotherapy System (RMRS) (FDA 510(k) Clearance)

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

DEN220014 · Reflexion Medical, Inc. · Radiology device
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Feb 2023
Decision
343d
Days
Class 2
Risk

DEN220014 is an FDA 510(k) submission (not cleared) for the RefleXion Medical Radiotherapy System (RMRS). Classified as Fludeoxyglucose F18-guided Radiation Therapy System (product code QVA), Class II - Special Controls.

Submitted by Reflexion Medical, Inc. (Hayward, US). The FDA issued a Not Cleared (DENG) decision on February 1, 2023 after a review of 343 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5060 - 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. High predicate equivalence gap. With 343 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.

View all Reflexion Medical, Inc. devices

Submission Details

510(k) Number DEN220014 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 23, 2022
Decision Date February 01, 2023
Days to Decision 343 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 107d · This submission: 343d
Pathway characteristics

Device Classification

Product Code QVA Fludeoxyglucose F18-guided Radiation Therapy System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5060
Definition A Fludeoxyglucose F18-guided Radiation Therapy System Is A Device That Combines The Functionality Of An Emission Computed Tomography Detection System And A Linear Accelerator. The Device Is Intended For Use With Approved Fludeoxyglucose F18. The Emission Computed Tomography Detection System Acquires Images Of Positron-emitting Fludeoxyglucose F18 For The Purpose Of Guiding The Delivery Of Megavoltage X-rays For Oncologic Treatment With Radiation Therapy Using An Fda Cleared, Authorized, Or Approved Linear Accelerator.
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.