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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 K203502
Device Name MEDO-Thyroid
Applicant
MEDO DX Pte. Ltd.
4560 TEC Centre, 10230 Jasper Avenue
Edmonton,  CA T5J4P6
Applicant Contact Dornoosh Zonoobi
Correspondent
MEDO DX Pte. Ltd.
4560 TEC Centre, 10230 Jasper Avenue
Edmonton,  CA T5J4P6
Correspondent Contact Dornoosh Zonoobi
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/30/2020
Decision Date 04/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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