FDA product code · Radiology

Fludeoxyglucose F18-Guided Radiation Therapy System

Name: FDA decisions, review times, recalls and adverse event reports for product code QVA
Creator: 510(k) Report

QVAClass II21 CFR 892.5060510(k) required2 decisions since 20230 recalls

2 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 170 days (half between 170 and 170). No recall names this code. The most-cited predicate is DEN220014, named by 1 later device.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, radiology panel

Twenty years of QVA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QVA

1in 2025

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QVA

Too few QVA 510(k)s in any year since 2007 to give a median.

Recalls per year · QVA

No recall names QVA since 2007.

Adverse event reports per year · QVA

9in 2025

2007high 9 (2025) · low 0 (2007)2025

MAUDE reports naming product code QVA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	1
2024	0	—	0
2025	1	—	9
2026	0	—	—

FIG. 1 — QVA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QVA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Fludeoxyglucose F18-Guided Radiation Therapy System

Which predicates do QVA devices cite most?

Which QVA devices have the deepest lineage?

What has FDA decided in QVA lately?