Arterys MICA
Arterys Inc.Arterys MICA is a software platform designed to display, process, store, and transfer medical imaging data, including CT and MR images. It features modules specialized for cardiac and oncology workflows, providing quantitative analysis to aid clinicians in diagnosis. The software runs on standard computers via a web browser and supports enhanced image viewing and lesion evaluation for clinical decision support.
Intended Use
Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, excluding mammography. It provides storage, filtering, digital manipulation, and quantitative measurements. The Cardio AI module analyzes the heart and its major vessels using multi-slice, multi-phase cardiovascular MR images, providing clinically relevant quantitative data. The Oncology AI module assists in assessing and documenting changes in morphological activity of lesions at diagnostic and therapy follow-up examinations. It is intended as a support tool for trained healthcare professionals to aid in diagnosis but does not directly generate diagnosis or potential findings.
Technology
Arterys MICA operates as a client-server software system, with a Linux server and a Chrome web browser client. It supports DICOM-compliant CT and MR images, includes modules for cardiac and oncology imaging workflows, offers 2D/3D image viewing and manipulation tools, quantitative measurement tools, semi-automated segmentation, and lesion tracking. It supports standard image storage and compression formats like JPEG2000, with improved multi-study viewing, filtering, and search functions.
Performance
Safety and performance were evaluated via software verification and validation testing according to IEC 62304 and ISO 14971 standards. The device underwent testing in compliance with FDA guidance documents on software in medical devices and cybersecurity management. The testing concluded no new safety or effectiveness concerns compared to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/30/2018
2 months - 2
FDA Approval
10/17/2018
Other devices from Arterys Inc.
- Arterys MICA2022 • 510K
- Arterys MICA2020 • 510K
- Arterys Oncology DL2018 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.