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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K192002
Device Name Lucy Point-of-Care Magnetic Resonance Imaging Device
Applicant
Hyperfine Research, Inc.
530 Old Whitfield St.,
Guildford,  CT  06437
Applicant Contact Brian Sawin
Correspondent
Hyperfine Research, Inc.
530 Old Whitfield St.,
Guildford,  CT  06437
Correspondent Contact Brian Sawin
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received07/26/2019
Decision Date 02/06/2020
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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