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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 K261081
Device Name Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
Applicant
Beijing Konted Medical Technology Co.,Ltd
Rm. 111, Bldg. 3, # 27,Yongwang Rd., Daxing Biological Pharm
Daxing District
Beijing,  CN 102629
Applicant Contact Deyi Zhu
Correspondent
Chengdu Lizhu Technology Co., Ltd.
#1179c, 1st Floor, # 2 Niusha Heng St., Jinjiang District
Chengdu,  CN 610065
Correspondent Contact Xuexia Ren
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/01/2026
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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