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

Name: FDA 510(k) clearance K254010
Creator: U.S. Food and Drug Administration
Published: 2026-01-14

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. Device class: 2.

Clearance details

Applicant: Brainlab SE
Product code: Product code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
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 ↗

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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.