QVA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fludeoxyglucose F18-Guided Radiation Therapy System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5060
- Medical specialty
- Radiology
- FDA 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.
- Adverse events (MAUDE)
- 2026: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RefleXion Medical Radiotherapy System, Reflexion X2 (K252071) | Reflexion Medical, Inc. | 2025-12-18 |
| RefleXion Medical Radiotherapy System (RMRS) (DEN220014) | Reflexion Medical, Inc. | 2023-02-01 |
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