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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 K192851
Device Name OASIS MRI System
Applicant
Hitachi Healthcare Americas
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact Aaron Pierce
Correspondent
Hitachi Healthcare Americas
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact Aaron Pierce
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/03/2019
Decision Date 02/21/2020
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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