FDA product code · Radiology

Source, Calibration, Sealed, Nuclear

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

IXDClass I21 CFR 892.1400510(k) exempt2 decisions since 19810 recalls

FDA lists IXD 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. 2 FDA decisions since 1981. 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 IXD 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 · IXD

FDA has decided no IXD device since 2007.

Median 510(k) review, days · IXD

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

Recalls per year · IXD

No recall names IXD since 2007.

Adverse event reports per year · IXD

1in 2013

2007high 2 (2008) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	2
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in IXD? 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

Source, Calibration, Sealed, Nuclear

What has FDA decided in IXD lately?