EXACTRAC 4.0 AND EXACTRAC X-RAY 6D— 510(k) K040585

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K040585 for EXACTRAC 4.0 AND EXACTRAC X-RAY 6D, Substantially Equivalent on 2004-05-11. Applicant: Brainlab AG.

Clearance details

Applicant: Brainlab AG
Product code: Code IYE
Advisory panel: Radiology
Date received: 2004-03-05
Decision date: 2004-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heimstetten, DE

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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.