INTRA OPERATIVE RADIATION THERAPY— 510(k) K004023

Substantially Equivalent

Arplay Medical S.A.

FDA 510(k) clearance K004023 for INTRA OPERATIVE RADIATION THERAPY, Substantially Equivalent on 2001-09-21. Applicant: Arplay Medical S.A..

Clearance details

Applicant: Arplay Medical S.A.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2000-12-27
Decision date: 2001-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Izeure, Cote D'Or, FR

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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.