510(k) Report

FDA applicant

Mci Optonix, Inc.

Cedar Knolls, NJ4 decisions1990–19950 recalls

FDA records 4 decisions for Mci Optonix, Inc. (Cedar Knolls, NJ) from 1990 to 1995: 4 510(k) clearances. Most are in product codes EAM (Screen, Intensifying, Radiographic) and IXA (Cassette, Radiographic Film). 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 Mci Optonix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mci Optonix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mci Optonix, 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?

  • EAMScreen, Intensifying, Radiographic2decisions
  • IXACassette, Radiographic Film2decisions

What has FDA decided for it lately?

  • K953444Mci Optonix Economy CassetteMci Optonix, Inc. · 1995
  • K945039Mci Optonix Cassette Okamoto CasseteMci Optonix, Inc. · 1994
  • K941023Rarex Green FastMci Optonix, Inc. · 1994
  • K902039Rarex & Optex X-Ray ScreensMci Optonix, Inc. · 1990

All 4 as Mci Optonix, Inc. →