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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 K212419
Device Name Magnifico Open, Magnifico MSK
Applicant
Esaote, S.p.A.
Via Enrico Melen 77
Genoa,  IT 16152
Applicant Contact Alberto Carcagni
Correspondent
Esaote, S.p.A.
Via Enrico Melen 77
Genoa,  IT 16152
Correspondent Contact Alberto Carcagni
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/04/2021
Decision Date 02/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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