BEAM MODULATOR, MODEL 4513 332 8000— 510(k) K042794

Substantially Equivalent

Elekta , Ltd.

FDA 510(k) clearance K042794 for BEAM MODULATOR, MODEL 4513 332 8000, Substantially Equivalent on 2005-01-31. Applicant: Elekta , Ltd..

Clearance details

Applicant: Elekta , Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2004-10-07
Decision date: 2005-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, 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.