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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 K152309
FOIA Releasable 510(k) K152309
Device Name LOGIQ E9, LOGIQ E9 XDClear 2.0
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact BRYAN BEHN
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact BRYAN BEHN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/14/2015
Decision Date 09/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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