510(k) Report

FDA product code · Radiology

Generator, Low Voltage, Therapeutic X-Ray

IYDClass II21 CFR 892.5900510(k) required1 decision since 19930 recalls

1 FDA decision since 1993. 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 IYD 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 · IYD

FDA has decided no IYD device since 2007.

Median 510(k) review, days · IYD

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

Recalls per year · IYD

No recall names IYD since 2007.

Adverse event reports per year · IYD

5in 2023

2023: 5
2007high 5 (2023) · low 0 (2007)2025

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

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—05
20240—00
20250—00
20260—0—
FIG. 1 — IYD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IYD? 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 892.5900.