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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 K121867
Device Name SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
Applicant
Chison Medical Imaging Co., Ltd.
#8, Xiang Nan Rd., Shuo Fang, New District
Wuxi,  CN 214142
Correspondent
Tuv Rheinland of North America, Inc.
1279 Quarry Lane, Suite A
Pleasanton,  CA  94566
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/26/2012
Decision Date 08/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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