FDA product code · Radiology

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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

QDQClass II21 CFR 892.2090510(k) required40 decisions since 20180 recalls

40 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 168 days (half between 116 and 205). No recall names this code. The most-cited predicate is K181704, named by 6 later devices.

A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information…

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 QDQ 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 · QDQ

10so far in 2026, the most since 2007

2007high 10 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QDQ

216in 2025

2007high 216 (2025) · low 131 (2022)2026

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

Recalls per year · QDQ

No recall names QDQ since 2007.

Adverse event reports per year · QDQ

No MAUDE report names QDQ 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	2	—	0
2019	2	—	0
2020	3	173	0
2021	5	169	0
2022	4	131	0
2023	2	—	0
2024	7	153	0
2025	5	216	0
2026	10	154	—

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

Planning a device in QDQ? 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 892.2090.

QBS Radiological Computer Assisted…

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Which predicates do QDQ devices cite most?

Which QDQ devices have the deepest lineage?

What has FDA decided in QDQ lately?

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