510(k) Report

FDA applicant

Is2 Medical Systems, Inc.

Ottawa, Ontario, CA1 decision2003–20030 recalls

FDA records 1 decision for Is2 Medical Systems, Inc. (Ottawa, Ontario, CA) in 2003: 1 510(k) clearance. All are in product code KPS (System, Tomography, Computed, Emission). 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 Is2 Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Is2 Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Is2 Medical 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, Emission1decision

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.

  • K033199Compact Digital Cardiac Camera (CDCC)Is2 Medical Systems, Inc. · 20031cites it

What has FDA decided for it lately?

  • K033199Compact Digital Cardiac Camera (CDCC)Is2 Medical Systems, Inc. · 2003

The one decision as Is2 Medical Systems, Inc. →