510(k) Report

FDA product code · Radiology

Generator, Orthovoltage, Therapeutic X-Ray

IYCClass II21 CFR 892.5900510(k) required0 decisions0 recalls

0 FDA decisions. 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 IYC 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 · IYC

FDA has decided no IYC device since 2007.

Median 510(k) review, days · IYC

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

Recalls per year · IYC

No recall names IYC since 2007.

Adverse event reports per year · IYC

2in 2022

2016: 12017: 12022: 2
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code IYC, 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—01
20170—01
20180—00
20190—00
20200—00
20210—00
20220—02
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — IYC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IYC? 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.