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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 K221393
Device Name Swoop Portable MR Imaging System
Applicant
Hyperfine, Inc.
351 New Whitfield Street
Guilford,  CT  06437
Applicant Contact Christine Kupchick
Correspondent
Hyperfine, Inc.
351 New Whitfield Street
Guilford,  CT  06437
Correspondent Contact Christine Kupchick
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received05/13/2022
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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