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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 K172110
Device Name ECHELON OVAL V6.0A MRI System
Applicant
Hitachi Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact Doug Thistlethwaite
Correspondent
Hitachi Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact Doug Thistlethwaite
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/13/2017
Decision Date 01/11/2018
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
Recalls CDRH Recalls
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