Cvi42 Auto Imaging Software Application

Automated Radiological Image Processing Software

Circle Cardiovascular Imaging Inc

The following data is part of a premarket notification filed by Circle Cardiovascular Imaging Inc with the FDA for Cvi42 Auto Imaging Software Application.

Pre-market Notification Details

Device IDK213998
510k NumberK213998
Device Name:Cvi42 Auto Imaging Software Application
ClassificationAutomated Radiological Image Processing Software
Applicant Circle Cardiovascular Imaging Inc Suite 1100 - 800 5th Ave SW Calgary,  CA T2P 3T6
ContactSydney Toutant
CorrespondentSydney Toutant
Circle Cardiovascular Imaging Inc Suite 1100 - 800 5th Ave SW Calgary,  CA T2P 3T6
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-21
Decision Date2022-07-28

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