FDA product code · Radiology

Programmer, Changer, Film/Cassette, Radiographic

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

IZPClass II21 CFR 892.1870510(k) exempt10 decisions since 19840 recalls

FDA lists IZP 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. 10 FDA decisions since 1984. 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 IZP 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 · IZP

FDA has decided no IZP device since 2007.

Median 510(k) review, days · IZP

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

Recalls per year · IZP

No recall names IZP since 2007.

Adverse event reports per year · IZP

No MAUDE report names IZP since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
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 — IZP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IZP? 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

Programmer, Changer, Film/Cassette, Radiographic

What has FDA decided in IZP lately?