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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 K230856
Device Name BrainSpec Core™ Software
Applicant
BrainSpec, Inc
198 Tremont Street, #314
Boston,  MA  02116
Applicant Contact Alexandra Zimmerman
Correspondent
Helix Medical, LLC
711 SE 5th Ave
Pompano Beach,  FL  33060
Correspondent Contact Carolyn Guthrie
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
LNI  
Date Received03/29/2023
Decision Date 11/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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