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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 K260313
Device Name MD-6000S Bladder Scanner
Applicant
MEDA Co., Ltd.
F2c,F3d,F4c,F5, F6c, Bldg. C2,
Xinmao Science Skill Park, Huayuan Industry Developmet Area
Tianjin,  CN 300384
Applicant Contact Linda Zhang
Correspondent
MEDA Co., Ltd.
F2C, F3D, F4C, F5, F6C, Bldg. C2,
Xinmao Science Skill Park, Huayuan Industry Developmet Area
Tianjin,  CN 300384
Correspondent Contact Linda Zhang
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received01/30/2026
Decision Date 09/24/2026
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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