BRAINLAB LINAC HARDWARE— 510(k) K934657

Substantially Equivalent

Brainlab Med. Computersysteme GmbH

FDA 510(k) clearance K934657 for BRAINLAB LINAC HARDWARE, Substantially Equivalent on 1994-07-22. Applicant: Brainlab Med. Computersysteme GmbH.

Clearance details

Applicant: Brainlab Med. Computersysteme GmbH
Product code: Code IYE
Advisory panel: Radiology
Date received: 1993-09-21
Decision date: 1994-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, NY, US

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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.