510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN220014Unknown

RefleXion Medical Radiotherapy System (RMRS)

Reflexion Medical, Inc., Hayward CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220014 is the FDA 510(k) clearance record for RefleXion Medical Radiotherapy System (RMRS), a class II device, cleared for Reflexion Medical, Inc. on under FDA product code QVA (Fludeoxyglucose F18-Guided Radiation Therapy System). FDA's definition for product code QVA reads: "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...". FDA records list 3 510(k) clearances for Reflexion Medical, Inc., from to . As of , FDA records show no recalls naming DEN220014.

Clearance record

Decision date
Received
(343 days to decision)
Product code
QVA Fludeoxyglucose F18-Guided Radiation Therapy System
Regulation
21 CFR 892.5060
Device class
Class II
Review panel
Radiology
Applicant
Reflexion Medical, Inc. 25841 Industrial Blvd., Suite 275, Hayward CA
Third party review
No

Clearances, product code QVA

Trailing 12 months
1 clearance under product code QVA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QVA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260