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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 K202414
Device Name BrainInsight
Applicant
Hyperfine Research, Inc.
530 Old Whitfield St.,
Guildford,  CT  06437
Applicant Contact Robert Fasciano
Correspondent
Hyperfine Research, Inc.
530 Old Whitfield St.,
Guildford,  CT  06437
Correspondent Contact Robert Fasciano
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/24/2020
Decision Date 01/07/2021
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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