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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 K142341
Device Name X-RAY TV SYSTEM SONIALVISION G4
Applicant
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto,  JP 604-8511
Applicant Contact TOSHIO KADOWAKI
Correspondent
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502 -1328
Correspondent Contact DON KARLE
Regulation Number892.1650
Classification Product Code
JAA  
Date Received08/21/2014
Decision Date 03/06/2015
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
Recalls CDRH Recalls
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