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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K200356
Device Name MEDO ARIA
4560 TEC Centre, 10230 Jasper Avenue
Edmonton,  CA T5j4p6
Applicant Contact Dornoosh Zonoobi
32 Carpenter Street
SG 059911
Correspondent Contact Dornoosh Zonoobi
Regulation Number892.2050
Classification Product Code
Date Received02/13/2020
Decision Date 06/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No