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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 Doppler, Ultrasonic
510(k) Number K092907
Device Name DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR
Applicant
Shantou Institute of Ultrasonic Instuments
7263 Cronin Cir.
Dublin,  CA  94568
Applicant Contact BOB LEIKER
Correspondent
Shantou Institute of Ultrasonic Instuments
7263 Cronin Cir.
Dublin,  CA  94568
Correspondent Contact BOB LEIKER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/22/2009
Decision Date 03/05/2010
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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