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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 prioritization software for lesions
510(k) Number K223443
Device Name Viz AAA
Applicant
Viz. ai, Inc.
201 Mission St., 12th Floor
San Francisco,  CA  94105
Applicant Contact Pooja Shah
Correspondent
Viz. ai, Inc.
201 Mission St., 12th Floor
San Francisco,  CA  94105
Correspondent Contact Pooja Shah
Regulation Number892.2080
Classification Product Code
QFM  
Date Received11/14/2022
Decision Date 03/17/2023
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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