FDA product code · Radiology

System, Rf/Microwave Hyperthermia, Cancer Treatment

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

LOCClass IIIPMA required2 decisions since 19830 recalls

2 FDA decisions since 1983. 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 LOC 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 · LOC

FDA has decided no LOC device since 2007.

Median 510(k) review, days · LOC

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

Recalls per year · LOC

No recall names LOC since 2007.

Adverse event reports per year · LOC

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

Planning a device in LOC? 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, Rf/Microwave Hyperthermia, Cancer Treatment

What has FDA decided in LOC lately?