Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5060](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5060) → QVA — Fludeoxyglucose F18-Guided Radiation Therapy System

# QVA · Fludeoxyglucose F18-Guided Radiation Therapy System

_Radiology · 21 CFR 892.5060 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/QVA

## Overview

- **Product Code:** QVA
- **Device Name:** Fludeoxyglucose F18-Guided Radiation Therapy System
- **Regulation:** [21 CFR 892.5060](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5060)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/QVA/K252071.md) | RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. | Dec 18, 2025 | SESE |
| [DEN220014](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/QVA/DEN220014.md) | RefleXion Medical Radiotherapy System (RMRS) | Reflexion Medical, Inc. | Feb 1, 2023 | DENG |

## Top Applicants

- Reflexion Medical, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/QVA](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/QVA)

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