Cleared Special

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

K254010 · Brainlab SE · Radiology

Jan 2026

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K254010 is an FDA 510(k) clearance for the ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Brainlab SE (Munich, DE). The FDA issued a Cleared decision on January 14, 2026, 30 days after receiving the submission on December 15, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K254010 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2025
Decision Date	January 14, 2026
Days to Decision	30 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF