510(k) Report

FDA product code · Radiology

Collimator, Low Voltage, Therapeutic X-Ray

IYJClass 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 IYJ 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 · IYJ

FDA has decided no IYJ device since 2007.

Median 510(k) review, days · IYJ

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

Recalls per year · IYJ

No recall names IYJ since 2007.

Adverse event reports per year · IYJ

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code IYJ, 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—01
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 — IYJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IYJ? 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.