510(k) Report

FDA applicant

Eclipse Systems, Inc.

North Attleboro, MA2 decisions2000–20030 recalls

FDA records 2 decisions for Eclipse Systems, Inc. (North Attleboro, MA) from 2000 to 2003: 2 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Eclipse Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eclipse Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eclipse Systems, 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?

  • KPSSystem, Tomography, Computed, Emission2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K002229Wackers-Liu CQ SoftwareEclipse Systems, Inc. · 20001cites it

What has FDA decided for it lately?

  • K032500Modificarion to Wackers-Liu CQ SoftwareEclipse Systems, Inc. · 2003
  • K002229Wackers-Liu CQ SoftwareEclipse Systems, Inc. · 2000

All 2 as Eclipse Systems, Inc. →

Other applicant names beginning “Eclipse”

FDA records each applicant name separately; these may or may not be the same firm.

Eclipse Medcorp, LLC 4Eclipse Aesthetics, LLC 2Eclipse, Inc. 1Eclipse Ventures 1