FDA Device Intelligence
HomeDevice types › QVA

Fludeoxyglucose F18-Guided Radiation Therapy System

FDA product code QVA · Class 2 · Radiology

1
Registered devices
42
Adverse events
3
Recalls
2
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-02-09Reflexion Medical, Inc.Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied i
2025-07-22Reflexion Medical, Inc.Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead
2024-04-16Reflexion Medical, Inc.A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.