FDA applicant

Is2 Research, Inc.

Nepean, Ontario, CA7 decisions1998–20040 recalls

FDA records 7 decisions for Is2 Research, Inc. (Nepean, Ontario, CA) from 1998 to 2004: 7 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 3 predicates, 2 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 Is2 Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Is2 Research, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Is2 Research, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Is2 Research, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?