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510(k) K121499

FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM by Fujifilm Medical System U.S.A., Inc. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2012
Date Received
May 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

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