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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 K251901
Device Name Magnifico Open (100009900)
Applicant
Esaote, S.p.A.
Via Enrico Melen, 77
Genoa,  IT 16152
Applicant Contact Antonia Perrella
Correspondent
Esaote, S.p.A.
Via Enrico Melen, 77
Genoa,  IT 16152
Correspondent Contact Antonia Perrella
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/20/2025
Decision Date 03/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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