510(k) Report

FDA applicant

Computed Anatomy, Inc.

New York, NY4 decisions1986–19940 recalls

FDA records 4 decisions for Computed Anatomy, Inc. (New York, NY) from 1986 to 1994: 4 510(k) clearances. Most are in product codes HLQ (Keratoscope, Ac-Powered) and HJO (Biomicroscope, Slit-Lamp, Ac-Powered). 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 Computed Anatomy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Computed Anatomy, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Computed Anatomy, 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?

  • HLQKeratoscope, Ac-Powered3decisions
  • HJOBiomicroscope, Slit-Lamp, Ac-Powered1decision

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.

  • K944207Topographic Modeling System 2 TMS-2Computed Anatomy, Inc. · 19941cites it

What has FDA decided for it lately?

  • K944207Topographic Modeling System 2 TMS-2Computed Anatomy, Inc. · 1994
  • K902012VKS-1 Video KeratoscopeComputed Anatomy, Inc. · 1990
  • K901363Topographic Modeling SystemComputed Anatomy, Inc. · 1990
  • K862379Corneal Modeling SystemComputed Anatomy, Inc. · 1986

All 4 as Computed Anatomy, Inc. →