510(k) Report

FDA applicant

Atomic Energy of Canada

Kanata, Ontario, Canada, CA6 decisions1977–19850 recalls

FDA records 6 decisions for Atomic Energy of Canada (Kanata, Ontario, Canada, CA) from 1977 to 1985: 6 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). 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 Atomic Energy of Canada’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Atomic Energy of Canada since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Atomic Energy of Canada’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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Other applicant names beginning “Atomic”

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