510(k) Report

FDA applicant

Infrared Imaging Systems, Inc.

Columbus, OH1 decision2004–20040 recalls

FDA records 1 decision for Infrared Imaging Systems, Inc. (Columbus, OH) in 2004: 1 510(k) clearance. All are in product code KZA (Device, Vein Location, Liquid Crystal). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Infrared Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Infrared Imaging Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KZADevice, Vein Location, Liquid Crystal1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042679IR ViewerInfrared Imaging Systems, Inc. · 20041cites it

What has FDA decided for it lately?

  • K042679IR ViewerInfrared Imaging Systems, Inc. · 2004

The one decision as Infrared Imaging Systems, Inc. →

Other applicant names beginning “Infrared”

FDA records each applicant name separately; these may or may not be the same firm.

Infrared Laboratory Systems, LLC (Dba Synermed) 3Infrared Sciences Corp. 1