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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
Predetermined Change
Control Plan Authorized		 No
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