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510(k) K252071

RefleXion Medical Radiotherapy System, Reflexion X2 by Reflexion Medical, Inc. — Product Code QVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2025
Date Received
July 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fludeoxyglucose F18-Guided Radiation Therapy System
Device Class
Class II
Regulation Number
892.5060
Review Panel
RA
Submission Type

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.

Other clearances by Reflexion Medical, Inc.

  • DEN220014 — RefleXion Medical Radiotherapy System (RMRS) (February 1, 2023)
  • K190978 — RefleXion Medical Radiotherapy System (March 12, 2020)

Other clearances for product code QVA

  • DEN220014 — RefleXion Medical Radiotherapy System (RMRS) (February 1, 2023)