510(k) Report

FDA product code · Radiology

Contrast Media, Ultrasound

MJSClass IIIPMA required0 decisions since 19950 recalls

0 FDA decisions since 1995. 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 MJS 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 · MJS

FDA has decided no MJS device since 2007.

Median 510(k) review, days · MJS

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

Recalls per year · MJS

No recall names MJS since 2007.

Adverse event reports per year · MJS

1in 2012

2007: 22009: 12012: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code MJS, 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—02
20080—00
20090—01
20100—00
20110—00
20120—01
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 — MJS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MJS? 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