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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K213829
Device Name SCENARIA View
Applicant
FUJIFILM Healthcare Corporation
2-1, Shintoyofuta
Kashiwa-Shi,  JP 277-0804
Applicant Contact Randy Vader
Correspondent
FUJIFILM Healthcare Americas Corporation
81 Hartwell Avenue, Suite 300
Lexington,  MA  02421
Correspondent Contact Dennis Domoracki
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/08/2021
Decision Date 05/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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