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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, Fluoroscopic, Image-Intensified
510(k) Number K131075
Device Name X-RAY TV SYSTEM SONIAL VISION G4
Applicant
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact DON KARLE
Correspondent
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact DON KARLE
Regulation Number892.1650
Classification Product Code
JAA  
Date Received04/17/2013
Decision Date 03/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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