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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 K162743
Device Name ViewPoint 6
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 Received09/30/2016
Decision Date 11/22/2016
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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