FDA product code QVA: Fludeoxyglucose F18-Guided Radiation Therapy System
QVA is the FDA product code for fludeoxyglucose f18-guided radiation therapy system. It is a Class II device, regulated under 21 CFR 892.5060 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under QVA, 1 in the last five years. The average 510(k) review took 170 days (median 170); 170 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 3 recalls for QVA devices, 3 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Fludeoxyglucose F18-Guided Radiation Therapy System |
| Device class | Class II |
| Regulation | 21 CFR 892.5060 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QVA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 170 |
Compare with all 510(k) review times · Search every QVA clearance
Top QVA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Reflexion Medical, Inc. | 1 | 2025-12-18 |
Most recent QVA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252071 | Reflexion Medical, Inc. | RefleXion Medical Radiotherapy System, Reflexion X2 | 2025-12-18 | 170 |
Recalls for QVA devices
3 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-02-09.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A9609 — Fludeoxyglucose f18 up to 15 millicuries
Frequently asked questions
What is FDA product code QVA?
QVA is the FDA product code for fludeoxyglucose f18-guided radiation therapy system. It is a Class II device, regulated under 21 CFR 892.5060 and reviewed by the Radiology panel.
What device class is QVA?
Class II, regulation 21 CFR 892.5060. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVA?
Across 1 cleared submissions the average was 170 days from receipt to decision (median 170).
Which companies have the most QVA clearances?
Reflexion Medical, Inc. (1).
Have QVA devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2026-02-09.
Next steps
- Run an FDA pathway report with predicate devices for product code QVA
- Run a recall and safety report across every QVA manufacturer
- Watch product code QVA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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