Cleared Traditional

K252071 - RefleXion Medical Radiotherapy System

K252071 is an FDA 510(k) clearance for RefleXion Medical Radiotherapy System, manufactured by Reflexion Medical, Inc.. The device is a Class 2 Radiology device with product code QVA cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K252071 · Reflexion Medical, Inc. · Radiology device
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Dec 2025
Decision
170d
Days
Class 2
Risk

K252071 is an FDA 510(k) clearance for the RefleXion Medical Radiotherapy System, Reflexion X2. 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 Cleared decision on December 18, 2025 after a review of 170 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Reflexion Medical, Inc. devices

FDA 510(k) Submission Details - K252071

510(k) Number K252071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2025
Decision Date December 18, 2025
Days to Decision 170 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 107d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QVA Device Classification - Class 2, Special Controls

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.