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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 K243142
Device Name Cranial 4Pi Immobilization
Applicant
Brainlab AG
Olof-Palme St. 9
Munich,  DE 81829
Applicant Contact Sadwini Suresh
Correspondent
Brainlab AG
Olof-Palme St. 9
Munich,  DE 81829
Correspondent Contact Sadwini Suresh
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/30/2024
Decision Date 06/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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