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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 K252709
Device Name Wireless Probe Type Ultrasound Scanner
Applicant
Xuzhou Yongkang Electronic Science Technology Co., Ltd.
1st & 2nd Floor, 6# Bldg., 1st Phase Economic Development
Manufacturing Zone, Liando U Valley,6# Leye Rd., Etdz
Xuzhou,  CN 221000
Applicant Contact Xiao Wan
Correspondent
Zhihe Info-Tech Co., Ltd.
Rm. 616, Bldg. 1, # 1 Huayun Rd., Industrial Park
Suzhou,  CN 215134
Correspondent Contact Rachel Yu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/27/2025
Decision Date 04/02/2026
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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