510(k) Report

FDA applicant

Cannon U.S.A., Inc.

Lake Success, NY2 decisions1994–19960 recalls

FDA records 2 decisions for Cannon U.S.A., Inc. (Lake Success, NY) from 1994 to 1996: 2 510(k) clearances. Most are in product codes LMA (Digitizer, Image, Radiological) and HKO (Refractometer, Ophthalmic). 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, radiology panel, where it files most

How often FDA has decided Cannon U.S.A., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cannon U.S.A., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cannon U.S.A., 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?

  • LMADigitizer, Image, Radiological1decision
  • HKORefractometer, Ophthalmic1decision

What has FDA decided for it lately?

  • K960839Film Scanner 300Cannon U.S.A., Inc. · 1996
  • K942242Auto Ref-Keratometer, RK-3Cannon U.S.A., Inc. · 1994

All 2 as Cannon U.S.A., Inc. →