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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K220815
Device Name BrainInsight
Hyperfine, Inc.
351 New Whitfield St
Guilford,  CT  06437
Applicant Contact Christine Kupchick
Hyperfine, Inc.
351 New Whitfield St
Guilford,  CT  06437
Correspondent Contact Christine Kupchick
Regulation Number892.2050
Classification Product Code
Date Received03/21/2022
Decision Date 07/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No