Arterys MICA
Arterys Inc.Arterys MICA is a medical diagnostic software that processes and analyzes medical imaging data, primarily MR and CT scans. It includes AI modules that assist clinicians in quantifying heart function and detecting, evaluating, and tracking lesions for oncology purposes. The software supports trained healthcare professionals by providing quantitative data and visualization tools to aid diagnosis and treatment follow-up.
Intended Use
Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. Includes Cardio AI for cardiac MR analysis and Oncology AI for lesion assessment in MR and CT images.
Technology
Software with client (web browser) and server (Linux OS) components. Modular image viewer with AI modules for cardiac function quantification from multi-slice, multi-phase velocity-encoded MR images and oncology lesion evaluation and documentation for MR and CT.
Performance
Device performance was verified through extensive software validation and verification testing according to IEC 62304 and ISO 14971 standards. Tests included display quality and performance comparison to predicate devices, with defect tracking and resolution.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/6/2019
6 months - 2
FDA Approval
3/25/2020
Other devices from Arterys Inc.
- Arterys MICA2022 • 510K
- Arterys MICA2018 • 510K
- Arterys Oncology DL2018 • 510K
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