FDA product code · Radiology

Radiological Computer-Assisted Prioritization Software For Lesions

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

QFMClass II21 CFR 892.2080510(k) required41 decisions since 20190 recalls

41 FDA decisions since 2019. 510(k) reviews decided 2021–2025 took a median of 144 days (half between 95 and 210). No recall names this code. The most-cited predicate is K190362, named by 6 later devices.

Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image…

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 QFM 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 · QFM

3in 2025

2007high 9 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QFM

100in 2025

2007high 206 (2023) · low 97 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QFM

No recall names QFM since 2007.

Adverse event reports per year · QFM

No MAUDE report names QFM since 2007.

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	4	97	0
2020	4	172	0
2021	5	187	0
2022	9	121	0
2023	8	206	0
2024	6	192	0
2025	3	100	0
2026	2	—	—

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

Planning a device in QFM? 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

Related product codes

Other codes under 21 CFR 892.2080.

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Radiological Computer-Assisted Prioritization Software For Lesions

Which predicates do QFM devices cite most?

Which QFM devices have the deepest lineage?

What has FDA decided in QFM lately?

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