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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 K221148
Device Name Vivid iq
Applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
9900 W. Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Lee Bush
Correspondent
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
9900 W. Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Lee Bush
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/20/2022
Decision Date 07/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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