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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 K251820
Device Name ViewMateTM Ultrasound System
Applicant
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Xiaozhen Ding
Correspondent
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Xiaozhen Ding
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/13/2025
Decision Date 09/12/2025
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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