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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 K261313
Device Name Vivid Explorer/Vivid Advanced/Vivid Focus
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Yuan Wang
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Yuan Wang
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITO   ITX   QIH  
Date Received04/21/2026
Decision Date 09/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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