Arterys Oncology DL
Arterys Inc.Arterys Oncology DL is a medical imaging software that helps clinicians view, compare, and analyze CT and MR images to detect and track lesions in cancer patients. It offers tools for 2D and 3D visualization, semi-automatic segmentation of lung nodules and liver lesions, and longitudinal tracking to support diagnosis and treatment follow-up.
Intended Use
A medical diagnostic application for viewing, manipulation, 3D visualization and comparison of medical images from CT or MR, supporting oncological workflow by helping confirm presence or absence of lesions, including evaluation, quantification, follow-up and documentation.
Technology
Software application supports viewing, manipulation, 3D visualization, semi-automatic volumetric segmentation for lung and liver lesions, co-registration, longitudinal tracking, and data reporting based on Lung-RADS and LI-RADS guidelines. Supports CT and MR modalities with multiple output formats including MIP and volume rendering.
Performance
The device underwent extensive non-clinical verification and validation including software testing for deep learning models on liver MR and lung MR, lung longitudinal tracking, and usability. It met design requirements and demonstrated safety and effectiveness equivalent to predicate devices, conducted in compliance with applicable standards including DICOM, IEC 62304, ISO 14971, and ISO 62366.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/16/2017
2 months - 2
FDA Approval
1/25/2018
Other devices from Arterys Inc.
- Arterys MICA2022 • 510K
- Arterys MICA2020 • 510K
- Arterys MICA2018 • 510K
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