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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 K201369
Device Name AVA (Augmented Vascular Analysis)
See-Mode Technologies Pte. Ltd.
32 Carpenter Street, #03-01
Singapore,  SG 059911
Applicant Contact Sadaf Monajemi
Matrix Medical Consulting, Inc.
8880 Rio San Diego Drive, Suite 800
San Diego,  CA  92108
Correspondent Contact Alan Donald
Regulation Number892.2050
Classification Product Code
Date Received05/22/2020
Decision Date 09/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No