510(k) Report

FDA product code · Radiology

System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)

KXZClass III21 CFR 884.2982PMA required7 decisions since 19770 recalls

7 FDA decisions since 1977. 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 KXZ 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 · KXZ

FDA has decided no KXZ device since 2007.

Median 510(k) review, days · KXZ

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

Recalls per year · KXZ

No recall names KXZ since 2007.

Adverse event reports per year · KXZ

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

Planning a device in KXZ? 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

Related product codes

Other codes under 21 CFR 884.2982.