ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface— 510(k) K254010

Substantially Equivalent

Brainlab SE

FDA 510(k) clearance K254010 for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface, Substantially Equivalent on 2026-01-14. Applicant: Brainlab SE.

Clearance details

Applicant: Brainlab SE
Product code: Code IYE
Advisory panel: Radiology
Date received: 2025-12-15
Decision date: 2026-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Munich, 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.