CRANIAL STEREOTACTIC EQUIPMENT— 510(k) K010065

Substantially Equivalent

Arplay Medical S.A.

FDA 510(k) clearance K010065 for CRANIAL STEREOTACTIC EQUIPMENT, Substantially Equivalent on 2002-07-02. Applicant: Arplay Medical S.A..

Clearance details

Applicant: Arplay Medical S.A.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2001-01-08
Decision date: 2002-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Izeure, Cote D'Or, FR

Download summary PDF View on FDA.gov ↗

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.