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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 K260111
Device Name Palmtop Ultrasound Diagnostic System (MT10P/MT10)
Applicant
Mytech Intelligence (Shenzhen) Co., Ltd.
Rm.605, 606, 615 & 616, Block R3-B, High-Tech Industrial
Village, # 018, S. 7th Gaoxin Rd., Gaoxin Community
Shenzhen,  CN 518000
Applicant Contact Xulei Shi
Correspondent
Dongguan Woer Biotechnology Consulting Co., Ltd.
Rm. 802, Bldg. 37, Sunshine Guangdong Garden
# 72, Hengli Zhongshan E. Rd., Hengli Town
Dongguan,  CN 5230000
Correspondent Contact Amos Zou
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/14/2026
Decision Date 05/14/2026
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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