BRAINLAB MASK SYSTEM— 510(k) K945903

Substantially Equivalent

Brainlab Med. Computersysteme GmbH

FDA 510(k) clearance K945903 for BRAINLAB MASK SYSTEM, Substantially Equivalent on 1995-06-05. Applicant: Brainlab Med. Computersysteme GmbH.

Clearance details

Applicant: Brainlab Med. Computersysteme GmbH
Product code: Code IYE
Advisory panel: Radiology
Date received: 1994-12-02
Decision date: 1995-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 85586 Poing/Munchen, DE

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.