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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 K061488
Device Name CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM
Applicant
Shantou Institute of Ultrasonic Instruments (Siui
7263 Cronin Circle
Dublin,  CA  94568
Applicant Contact BOB LEIKER
Correspondent
Shantou Institute of Ultrasonic Instruments (Siui
7263 Cronin Circle
Dublin,  CA  94568
Correspondent Contact BOB LEIKER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/31/2006
Decision Date 06/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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