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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K254010
Device Name ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
Applicant
Brainlab SE
Olof-Palme-Str.9
Munich,  DE 81829
Applicant Contact Sadwini Suresh
Correspondent
Brainlab SE
Olof-Palme-Str.9
Munich,  DE 81829
Correspondent Contact Sadwini Suresh
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/15/2025
Decision Date 01/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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