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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radiological computer-assisted triage and notification software
510(k) Number K210209
Device Name Viz ICH
Applicant
Viz.ai, Inc.
350 Rhode Island St, Suite 240
San Francisco,  CA  94103
Applicant Contact Gregory Ramina
Correspondent
Viz.ai, Inc.
350 Rhode Island St, Suite 240
San Francisco,  CA  94103
Correspondent Contact Gregory Ramina
Regulation Number892.2080
Classification Product Code
QAS  
Date Received01/26/2021
Decision Date 03/23/2021
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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