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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 K170978
Device Name Embrace Neonatal MRI System
Applicant
Aspect Imaging Ltd.
27 Shaked St.
Industrial Area Hevel Modi’in.,  IL 6085001
Applicant Contact Israel Citron
Correspondent
Aspect Imaging Ltd.
27 Shaked Street
Industrial Area, Hevel Modi'in, P.O. Box 926
Shoham,  IL 6085001
Correspondent Contact Israel Citron
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received04/03/2017
Decision Date 07/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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