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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 K261668
Device Name Venue Go
Applicant
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Karin Shimoni
Correspondent
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Karin Shimoni
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITO   ITX   QIH  
Date Received05/20/2026
Decision Date 08/07/2026
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		 No
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