Arterys MICA
Arterys Inc.Arterys MICA is a cloud-based medical imaging software that helps healthcare professionals view, process, and analyze medical images from CT and MRI scans. It includes AI modules that assist in cardiac and oncology evaluations by automating image quantification and lesion assessments, supporting clinicians in their diagnostic workflows.
Intended Use
Arterys MICA software is a medical diagnostic application for displaying, processing, storing, and transferring DICOM and non-DICOM medical data, supporting image and lesion evaluation in cardiac and oncology workflows.
Technology
Cloud-based software accessed via web browser that uses deep learning algorithms for segmentation, landmark identification, and quantification on multi-phase cardiac MR and oncology images. Includes modular components for image viewing and AI-assisted analysis.
Performance
The device has undergone extensive software validation and verification according to IEC 62304 and ISO 14971 standards. Performance was demonstrated through comparisons of AI-derived T1 and T2 cardiac MRI measures against vendor generated maps, showing accuracy within predefined limits. Clinical validation included testing on 90 cardiac MRI scans showing AI-generated contours comparable to ground truth.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/22/2020
1 year, 2 months - 2
FDA Approval
3/14/2022
Other devices from Arterys Inc.
- Arterys MICA2020 • 510K
- Arterys MICA2018 • 510K
- Arterys Oncology DL2018 • 510K
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