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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 K211406
Device Name OASIS MRI System
Applicant
Hitachi Healthcare Americas
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact Aaron Pierce
Correspondent
FUJIFILM Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact Aaron Pierce
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/06/2021
Decision Date 10/07/2021
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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