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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 K230986
Device Name Bladder Scanner
Applicant
Avantsonic Technology Co., Ltd.
2f, Bldg. 4a, # 21, Changkang Rd., Yuzui Town
Liangjiang New Area
Chongqing,  CN 401133
Applicant Contact Winnie Wang
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
2f, Bldg. 4a, # 21, Changkang Rd., Yuzui Tow
Liangjiang New Area
Chongqing,  CN 401133
Correspondent Contact Ray Wang
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received04/06/2023
Decision Date 12/29/2023
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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