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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)
Applicant
See-Mode Technologies Pte, Ltd.
32 Carpenter St., #03-01
Singapore,  SG 059911
Applicant Contact Sadaf Monajemi
Correspondent
Matrix Medical Consulting, Inc.
8880 Rio San Diego Dr. Suite 800
San Diego,  CA  92108
Correspondent Contact Alan Donald
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/22/2020
Decision Date 09/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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