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510(k) K231574

Scenaria View 4.2 by Fujifilm Healthcare Americas Corporation — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2023
Date Received
May 31, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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