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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 K253366
Device Name LOGIQ Fortis
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Lee Bush
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Lee Bush
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received09/30/2025
Decision Date 01/07/2026
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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