510(k) Report

FDA applicant

Chromagraphics, Inc.

Bethesda, MD1 decision1986–19860 recalls

FDA records 1 decision for Chromagraphics, Inc. (Bethesda, MD) in 1986: 1 510(k) clearance. All are in product code HIW (Anomaloscope). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Chromagraphics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Chromagraphics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Chromagraphics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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