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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 K261617
Device Name Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Na
Shenzhen,  CN 518057
Applicant Contact Jing Tang
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Na
Shenzhen,  CN 518057
Correspondent Contact Jing Tang
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/15/2026
Decision Date 10/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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