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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 SOUTH 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
Recalls CDRH Recalls
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