510(k) Report

FDA applicant

Opgal Optronic Industries

North Attleboro, MA1 decision1995–19950 recalls

FDA records 1 decision for Opgal Optronic Industries (North Attleboro, MA) in 1995: 1 510(k) clearance. All are in product code LHQ (System, Telethermographic (Adjunctive Use)). 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 Opgal Optronic Industries’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Opgal Optronic Industries since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Opgal Optronic Industries 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.

  • K951806Opgal Intraoperative Vascular Angiography System (Iva-2000)Opgal Optronic Industries · 19951cites it

What has FDA decided for it lately?

  • K951806Opgal Intraoperative Vascular Angiography System (Iva-2000)Opgal Optronic Industries · 1995

The one decision as Opgal Optronic Industries →