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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image Acquisition And/Or Optimization Guided By Artificial Intelligence
510(k) Number K261042
Device Name Lung Guidance
Applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Zahra Ghanian
Correspondent
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Zahra Ghanian
Classification Product Code
QJU  
Date Received03/31/2026
Decision Date 10/02/2026
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		 No
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