QVA · Fludeoxyglucose F18-Guided Radiation Therapy System
Radiology · 21 CFR 892.5060 · Class 2
Overview
| Product Code | QVA |
|---|---|
| Device Name | Fludeoxyglucose F18-Guided Radiation Therapy System |
| Regulation | 21 CFR 892.5060 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
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.
Classification Rationale
Class II (special controls). The device is granted under De Novo classification (DEN220014) and is subject to general controls and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the fludeoxyglucose F18-guided radiation therapy system is subject to the following special controls:
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. | Dec 18, 2025 | SESE |
| DEN220014 | RefleXion Medical Radiotherapy System (RMRS) | Reflexion Medical, Inc. | Feb 1, 2023 | DENG |
Top Applicants
- Reflexion Medical, Inc. — 2 clearances
