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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 K201971
Device Name SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
Applicant
CHISON Medical Technologies Co., Ltd.
#228, Changjiang E. Rd., Block 51 And 53,
Phase 5, Shuofang Industrial Park
Wuxi,  CN 214142
Applicant Contact Qifei Liu
Correspondent
CHISON Medical Technologies Co., Ltd.
#228, Changjiang E. Rd., Block 51 And 53, Phase 5,
Shuofang Industrial Park, Xinwu District
Wuxi,  CN 214142
Correspondent Contact Qifei Liu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/15/2020
Decision Date 02/25/2021
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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