Automated Radiological Image Processing Software

The following data is part of a premarket notification filed by with the FDA for Medo Aria.

Pre-market Notification Details

Device IDK200356
510k NumberK200356
Device Name:MEDO ARIA
ClassificationAutomated Radiological Image Processing Software
Applicant 4560 TEC Centre, 10230 Jasper Avenue Edmonton,  CA T5j4p6
ContactDornoosh Zonoobi
CorrespondentDornoosh Zonoobi 32 Carpenter Street SG 059911
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-13
Decision Date2020-06-11

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