LINEAR ACCELERATOR THERAC 25— 510(k) K837347

Substantially Equivalent

Atomic Energy of Canada

FDA 510(k) clearance K837347 for LINEAR ACCELERATOR THERAC 25, Substantially Equivalent on 1983-06-24. Applicant: Atomic Energy of Canada.

Clearance details

Applicant: Atomic Energy of Canada
Product code: Code IYE
Advisory panel: Radiology
Date received: 1983-04-04
Decision date: 1983-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanata, Ontario, Canada, CA

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.