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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K182750
Device Name 4D View
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics,
9900 W Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Tracey Ortiz
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics,
9900 W Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Tracey Ortiz
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/28/2018
Decision Date 12/21/2018
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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