510(k) Report

FDA product code · Radiology

Scanner, Fluorescent

JAOClass II21 CFR 892.1220510(k) required2 decisions since 19900 recalls

2 FDA decisions since 1990. 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 JAO 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 · JAO

FDA has decided no JAO device since 2007.

Median 510(k) review, days · JAO

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

Recalls per year · JAO

No recall names JAO since 2007.

Adverse event reports per year · JAO

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2025

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

Planning a device in JAO? 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