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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 K192917
Device Name ViewPoint 6
Applicant
Ge Medical Systems Ultrasound And
Primary Care Diagnostics, Llc
9900 W. Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Tracey Ortiz
Correspondent
Ge Medical Systems Ultrasound And
Primary Care Diagnostics, Llc
9900 W. Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Tracey Ortiz
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/15/2019
Decision Date 01/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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