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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K231498
Device Name TraumaCad Neo
Applicant
Brainlab , Ltd.
35 Efal St.
Petach-Tikva,  IL 4951132
Applicant Contact Yael Guttentag
Correspondent
Brainlab , Ltd.
35 Efal St.
Petach-Tikva,  IL 4951132
Correspondent Contact Yael Guttentag
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/24/2023
Decision Date 11/20/2023
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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