MEDICAL LINEAR ACCELERATOR— 510(k) K935615

Substantially Equivalent

Accelerator Systems Intl., Inc.

FDA 510(k) clearance K935615 for MEDICAL LINEAR ACCELERATOR, Substantially Equivalent on 1995-06-09. Applicant: Accelerator Systems Intl., Inc..

Clearance details

Applicant: Accelerator Systems Intl., Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1993-11-22
Decision date: 1995-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

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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.