510(k) Report

FDA product code · Radiology

Media, Reusable Image

LQAClass I21 CFR 892.1840510(k) exempt1 decision since 19860 recalls

FDA lists LQA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 892.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1986. No recall names this code.

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 LQA 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 · LQA

FDA has decided no LQA device since 2007.

Median 510(k) review, days · LQA

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

Recalls per year · LQA

No recall names LQA since 2007.

Adverse event reports per year · LQA

No MAUDE report names LQA since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — LQA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LQA? 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

What has FDA decided in LQA lately?

  • K854407Digirad Reusable Image MediaDigirad Corp. · 1986

The one LQA decision →

Related product codes

Other codes under 21 CFR 892.1840.

IWZ Film, Radiographic