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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 K191347
Device Name Paragon XHD Diagnostic Ultrasound System
Applicant
Shenzhen Wisonic Medical Technology Co. , Ltd.
1st, 2nd & 5th Floor, # 6 Bldg., Pingshan Tech Park,
Taoyuan St., Nanshan
Shenzhen,  CN 518055
Applicant Contact Jiang Xiaosan
Correspondent
Shenzhen Wisonic Medical Technology Co. , Ltd.
1st, 2nd & 5th Floor, # 6 Bldg., Pingshan Tech Park,
Taoyuan St., Nanshan
Shenzhen,  CN 518055
Correspondent Contact Jiang Xiaosan
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/20/2019
Decision Date 02/07/2020
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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