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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 K230208
Device Name Swoop® Portable MR Imaging System™
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 Number892.1000
Classification Product Code
Subsequent Product Code
Date Received01/25/2023
Decision Date 02/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No