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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 K180161
Device Name Viz CTP
Applicant
Viz.ai, Inc.
855 El Camino Real Suit 13A-252
Palo Alto,  CA  94301
Applicant Contact Gregory Ramina
Correspondent
Viz.ai, Inc.
855 El Camino Real Suit 13A-252
Palo Alto,  CA  94301
Correspondent Contact Gregory Ramina
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/19/2018
Decision Date 04/20/2018
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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