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510(k) K152294

FDR Visionary Suite by Shimadzu Corporation — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2016
Date Received
August 13, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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