510(k) Report

FDA applicant

Medhot Thermal Imaging, Inc.

Great Neck, NY1 decision2006–20061 recall

FDA records 1 decision for Medhot Thermal Imaging, Inc. (Great Neck, NY) in 2006: 1 510(k) clearance. All are in product code LHQ (System, Telethermographic (Adjunctive Use)). 1 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 Medhot Thermal Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medhot Thermal Imaging, Inc. since 2007.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medhot Thermal Imaging, 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

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.

  • K063047Medhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. · 20061cites it

What has FDA decided for it lately?

  • K063047Medhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. · 20061 recall

The one decision as Medhot Thermal Imaging, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K063047MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body…Jan 14, 2017Class II