M3 (MICRO-MULTILEAF COLLIMATOR)— 510(k) K020860

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K020860 for M3 (MICRO-MULTILEAF COLLIMATOR), Substantially Equivalent on 2002-06-06. Applicant: Brainlab AG.

Clearance details

Applicant: Brainlab AG
Product code: Code IYE
Advisory panel: Radiology
Date received: 2002-03-18
Decision date: 2002-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heimstetten, 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.