Arterys Inc. AMM7 Arterys MICA

iQ-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable brain structures from a set of brain MRI scans. It is intended to accelerate and improve the quantification of brain structures that would otherwise require a manual process of identifying, annotating, and measuring regions of interest in brain MRI scans. iQ-solutions™ consists of both cross-sectional and longitudinal analysis pipelines. • The cross-sectional pipeline is intended to conduct structure segmentation and volume analysis on brain MRI scans at a single time point.• The longitudinal pipeline is intended to conduct volume change analysis on a single patient’s MRI scans acquired on the same scanner, with consistent image acquisition protocol and with consistent contrast at two different time points. The results of the cross-sectional pipeline cannot be compared with the results of the longitudinal pipeline.

Version 6.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement. Version 7.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN), globus pallidus externa and interna (GPe and GPi, respectively) and the ventral intermediate nucleus (Vim) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement.

MD EchoPAC Software Only v206

MD EchoPAC Plug-in v206

iQ-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable brain structures from a set of brain MRI scans. It is intended to accelerate and improve the quantification of brain structures that would otherwise require a manual process of identifying, annotating, and measuring regions of interest in brain MRI scans. iQ-solutions™ consists of both cross-sectional and longitudinal analysis pipelines. • The cross-sectional pipeline is intended to conduct structure segmentation and volume analysis on brain MRI scans at a single time point.• The longitudinal pipeline is intended to conduct volume change analysis on a single patient’s MRI scans acquired on the same scanner, with consistent image acquisition protocol and with consistent contrast at two different time points. The results of the cross-sectional pipeline cannot be compared with the results of the longitudinal pipeline.

Version 6.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement. Version 7.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN), globus pallidus externa and interna (GPe and GPi, respectively) and the ventral intermediate nucleus (Vim) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement.