510(k) Report

FDA product code · Radiology

Ultrasound, Hyperthermia, Cancer Treatment

LSYClass IIIPMA required0 decisions since 20050 recalls

0 FDA decisions since 2005. 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 LSY 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 · LSY

FDA has decided no LSY device since 2007.

Median 510(k) review, days · LSY

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

Recalls per year · LSY

No recall names LSY since 2007.

Adverse event reports per year · LSY

No MAUDE report names LSY since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
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 — LSY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LSY? 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