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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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