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Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers and on monitors/screens that meet appropriate technical specifications for image diagnosis. Arterys MICA includes an optional Cardio AI module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) imges. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions. Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Arterys MICA, already cleared as per the predicate, is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Pre-existing DICOM images, such as CT or MR, are uploaded into Arterys MICA from a PACS or a scanner. Arterys MICA is completely hosted in the cloud and is accessed using a compatible web browser by navigating to the following https://app.arterys.com. Cloud servers are provided by Amazon Web Services (AWS) and service is accessible globally. The Viewer AI application of Arterys MICA is designed around a modular architecture of separate components that make up a basic image viewer. These include the Studylist, from which studies are selected and opened, the image display (2D, 3D, MIP, etc), view synchronization, metadata information, and various navigational, measurement, and other action tools. Functionality provided by the Viewer AI is extended by the additional Cardio AI and Oncology AI application modules which add support for specific clinical workflows: - Cardiac Workflow Module: Evaluates multi-slice and multi-phase velocity-encoded . cardiovascular magnetic resonance (MR) images to quantify blood flow and ventricular function. In addition, perfusion and delayed enhancement datasets are analyzed and quantified, and for parametric mapping, T1, T2, and T2* values are obtained to assess tissue changes in the myocardium, as well as ECV calculations. - Arterys MICA includes an optional Oncology AI module which provides analytical tools ● to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions. Arterys MICA uses many deep learning algorithms to reduce many tedious, time-consuming manual steps, such as segmentation, landmark identification, etc. The results of these AI models are available on-screen to the user for further review and editing. The software does not perform any functions that could not be accomplished by a trained user with a manual method; the purpose of the automation is to save time and automate potential error-prone manual tasks, while allowing the results to be reviewed as per the normal clinical workflow. NOTE: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of images. Artervs MICA software is a complement to these standard procedures.

Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers and on monitors/screens that meet appropriate technical specifications for image diagnosis. Arterys MICA includes an optional Cardio AI module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions. Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Arterys MICA, already cleared as per the predicate, is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Pre-existing DICOM images, such as CT or MR, are uploaded into Arterys MICA from a PACS or a scanner. The software has two components: i) client, and ii) server. The client software (i) can be used in a Chrome desktop web browser. The server software (ii) runs on the Linux operating system. The Viewer application of Arterys MICA is designed around a modular architecture of separate components that make up a basic image viewer. These components include the Worklist, from which studies are selected and opened, the Uploads list that displays all uploaded studies for the current organization, and the basic image display itself, which allows for viewing and working with 2D and 3D images. Functionality provided by the Viewer is extended by the additional Cardio AI and Oncology AI (Oncology AI: Lung AI and Oncology AI: Liver AI) application modules which add support for specific clinical workflows: - Cardiac Workflow Module: evaluates multi-slice and multi-phase velocity-encoded cardiovascular MR images to quantify blood flow and ventricular function. - Oncology Workflow Module: supports the oncological workflow by helping the user confirm the absence or presence of lesions including evaluation, quantification, follow-up and documentation of any such lesions within MR or CT images.

Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers. Arterys MICA includes an optional Cardio Al module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions. Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/ or diagnosis, but it does not directly generate any diagnosis or potential findings.

Arterys MICA is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Arterys MICA can also be used for analyzing multi-slice and multi-phase computed tomography (CT) or magnetic resonance (MR) image. Pre-existing CT or MR images are uploaded into Arterys MICA in a DICOM format from PACS or a scanner. The software has two components: i) client, and ii) server. The client software (i) can be used in a Chrome desktop web browser. The server software (ii) runs on the Linux operating system. The basic image Viewer application of Arterys MICA is designed around a modular architecture of separate components that make up the basic image Viewer. These components include the Worklist, from which studies are selected and opened, the Uploads list that displays all uploaded studies for the current organization and the basic image Viewer itself, which allows for viewing and working with 2D and 3D images. Functionality provided by the basic image Viewer is extended by additional Cardio Al and Oncology AI application modules and can add support for specific clinical workflows. The Cardio module adds support for flow-4D studies and provides additional functionality specific to cardiac studies. The Oncology module adds functionality specific to evaluating and measuring lesions, including lung and liver lesions/nodules.

Arterys Oncology DL is a medical diagnostic application for viewing, manipulation and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. Arterys Oncology DL enables visualization of information that would otherwise have to be visually compared disjointedly. Arterys Oncology DL provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. Arterys Oncology DL is designed to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Arterys Oncology DL is a complement to these standard procedures.

This traditional 510(k) is being submitted for Arterys Oncology DL which is intended for viewing, manipulation, 3D-visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. The software supports the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, follow-up and documentation of any such lesions. Key features of the software are: - 2D and 3D visualization and comparative review - Manual volumetric segmentation - Semi-automatic volumetric segmentation of lung nodules and liver lesions - Co-registration - Longitudinal tracking - Nodule/lesion size quantifications - Data reporting based on Lung-RADS and LI-RADS guidelines

Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis. but it does not directly generate any diagnosis or potential findings. The following visualization, quantification and data-reporting functionalities are provided by the software: Visualization: - 2D image review - - 3D image review by means of MIP, MinIP, Surface or Average - - Multi-planar reconstruction (MPR) views (axial, coronal, sagittal, and oblique) - - Image navigation tools - - Cine play - Quantification: - Distance and area measurements - Data reporting: The distance, area, and user-selected annotated images are displayed to the user within the software client web browser. The user has the option to save the data for later use. The user can also send the data to PACS, for review.

Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by Arterys Cardio DL is intended to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.

The Arterys Software consists of software that analyzes DI COM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Software specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by the Arterys Software is intended to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

The Arterys Software is a web-accessible image post-processing analysis software device for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for the analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. The Arterys Software is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.