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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 K241133
Device Name Magnifico Open (100009900); Magnifico MSK ( 100009910)
Applicant
Esaote, S.P.A.
Via Melen 77
Genova,  IT 16152
Applicant Contact Alberto Carcagnì
Correspondent
Esaote, S.P.A.
Via Melen 77
Genova,  IT 16152
Correspondent Contact Alberto Carcagnì
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/24/2024
Decision Date 06/26/2024
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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