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510(k) DEN220014

RefleXion Medical Radiotherapy System (RMRS) by Reflexion Medical, Inc. — Product Code QVA

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 1, 2023
Date Received
February 23, 2022
Clearance Type
Direct
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.

  • K252071 — RefleXion Medical Radiotherapy System, Reflexion X2 (December 18, 2025)
  • K190978 — RefleXion Medical Radiotherapy System (March 12, 2020)

Other clearances for product code QVA

  • K252071 — RefleXion Medical Radiotherapy System, Reflexion X2 (December 18, 2025)