FDA product code · Radiology

Imager, Breast, Electrical Impedance

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

NCLClass IIIPMA required1 decision since 19990 recalls

1 FDA decision since 1999. 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 NCL 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 · NCL

FDA has decided no NCL device since 2007.

Median 510(k) review, days · NCL

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

Recalls per year · NCL

No recall names NCL since 2007.

Adverse event reports per year · NCL

No MAUDE report names NCL 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 — NCL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NCL? 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

Imager, Breast, Electrical Impedance

What has FDA decided in NCL lately?