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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 Echo, Ultrasonic
510(k) Number K201316
Device Name Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
Applicant
Suzhou Peaksonic Medical Technology Co., Ltd.
2a, W. Side Of Bldg. G4, Kunshan Hi-Tech Medical Device
Industrial Park
Qiandeng, Kunshan, Suzhou,  CN 215341
Applicant Contact Calvin Ma
Correspondent
Suzhou Peaksonic Medical Technology Co., Ltd.
2a, W. Side Of Bldg. G4, Kunshan Hi-Tech Medical Device
Industrial Park
Qiandeng, Kunshan, Suzhou,  CN 215341
Correspondent Contact Calvin Ma
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received05/18/2020
Decision Date 02/26/2021
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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