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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 K250087
Device Name Vscan Air
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  
Date Received01/14/2025
Decision Date 05/01/2025
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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