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510(k) K131075

X-RAY TV SYSTEM SONIAL VISION G4 by Shimadzu Corp. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2014
Date Received
April 17, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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