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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 K251985
Device Name LOGIQ E10
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
3200 N Grandview Blvd.
Waukesha,  WI  53182
Applicant Contact Bryan Behn
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics
3200 N Grandview Blvd.
Waukesha,  WI  53182
Correspondent Contact Bryan Behn
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received06/27/2025
Decision Date 10/29/2025
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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