Product code QVA— Radiology
RefleXion Medical Radiotherapy System (RMRS)
- Classification name
- Fludeoxyglucose F18-Guided Radiation Therapy System
- Device class
- Class 2
- Regulation
- 21 CFR 892.5060
- Advisory panel
- Radiology
- Total cleared
- 2
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QVA
FDA has cleared devices under product code QVA between 2023 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2023
Top applicants under product code QVA
Recent clearances under product code QVA
Data sourced from openFDA. This site is unofficial and independent of the FDA.