510(k) Report

FDA applicant

Dorex, Inc.

Orange, CA2 decisions1981–20020 recalls

FDA records 2 decisions for Dorex, Inc. (Orange, CA) from 1981 to 2002: 2 510(k) clearances. Most are in product codes LHQ (System, Telethermographic (Adjunctive Use)) and IYM (System, Telethermographic, Infrared). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Dorex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dorex, 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?

  • LHQSystem, Telethermographic (Adjunctive Use)1decision
  • IYMSystem, Telethermographic, Infrared1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K023434Dorex Spectrum 9000MB Thermography SystemDorex, Inc. · 20021cites it
  • K812799DCATSDorex, Inc. · 19811cites it

What has FDA decided for it lately?

  • K023434Dorex Spectrum 9000MB Thermography SystemDorex, Inc. · 2002
  • K812799DCATSDorex, Inc. · 1981

All 2 as Dorex, Inc. →