MEDO-Thyroid

Automated Radiological Image Processing Software

MEDO DX Pte. Ltd.

The following data is part of a premarket notification filed by Medo Dx Pte. Ltd. with the FDA for Medo-thyroid.

Pre-market Notification Details

Device IDK203502
510k NumberK203502
Device Name:MEDO-Thyroid
ClassificationAutomated Radiological Image Processing Software
Applicant MEDO DX Pte. Ltd. 4560 TEC Centre, 10230 Jasper Avenue Edmonton,  CA T5j4p6
ContactDornoosh Zonoobi
CorrespondentDornoosh Zonoobi
MEDO DX Pte. Ltd. 4560 TEC Centre, 10230 Jasper Avenue Edmonton,  CA T5j4p6
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-30
Decision Date2021-04-23

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.