FDA product code · Radiology

System, X-Ray, Fluoroscopic, Non-Image-Intensified

Name: FDA decisions, review times, recalls and adverse event reports for product code JAB
Creator: 510(k) Report

JABClass II21 CFR 892.1660510(k) required2 decisions since 19810 recalls

2 FDA decisions since 1981. 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 JAB 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 · JAB

FDA has decided no JAB device since 2007.

Median 510(k) review, days · JAB

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

Recalls per year · JAB

No recall names JAB since 2007.

Adverse event reports per year · JAB

No MAUDE report names JAB since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — JAB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JAB? 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

System, X-Ray, Fluoroscopic, Non-Image-Intensified

What has FDA decided in JAB lately?