Arterys Cardio DL
ARTERYS INC.Arterys Cardio DL is an AI-powered software that analyzes cardiovascular MRI scans to quantify blood flow and heart function. It helps cardiologists and radiologists by providing clinically relevant, reproducible quantitative data from MRI images, supporting clinical decision-making without giving direct medical advice.
Intended Use
Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. It specifically analyzes blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images, providing clinically-relevant and reproducible, quantitative data to support qualified cardiologists, radiologists, or licensed professional healthcare practitioners for clinical decision-making.
Technology
Arterys Cardio DL is a web-accessible image post-processing software that visualizes and quantifies cardiovascular MR images in DICOM format through manual and semi-automatic border detection. It supports image visualization in 2D, 3D, multi-planar reconstruction views, and provides measurements such as anatomy segmentation, cardiac function metrics, flow quantification, and phase correction. It is compatible with 1.5T and 3.0T MR scanners and outputs quantitative data for clinical use.
Performance
The software underwent safety and performance evaluation including software verification and validation testing per IEC 62304 and FDA Guidance for software in medical devices. Validation confirms the device raises no new safety and effectiveness concerns compared to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/18/2016
1 month - 2
FDA Approval
1/5/2017
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