BRAINLAB MICRO MULTI-LEAF COLLIMATOR— 510(k) K970586

Name: FDA 510(k) clearance K970586
Creator: U.S. Food and Drug Administration
Published: 1997-05-12

Substantially Equivalent

Brainlab Med. Computersysteme GmbH

FDA 510(k) clearance K970586 for BRAINLAB MICRO MULTI-LEAF COLLIMATOR, Substantially Equivalent on 1997-05-12. Applicant: Brainlab Med. Computersysteme GmbH. Device class: 2.

Clearance details

Applicant: Brainlab Med. Computersysteme GmbH
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1997-02-14
Decision date: 1997-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 85551 Heimstetten, DE

Download summary PDF View on FDA.gov ↗

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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.