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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K061641
Device Name ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
Applicant
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact RANDAL WALKER
Correspondent
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact RANDAL WALKER
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received06/12/2006
Decision Date 07/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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