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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 K211818
Device Name Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
530 Old Whitfield Street
Guilford,  CT  06437
Applicant Contact Christine Kupchick
Hyperfine, Inc.
530 Old Whitfield Street
Guilford,  CT  06437
Correspondent Contact Christine Kupchick
Regulation Number892.1000
Classification Product Code
Subsequent Product Code
Date Received06/11/2021
Decision Date 07/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No