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AccuCTP Pro is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices. AccuCTP Pro provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP), which can visualize and analyze dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

AccuCTP Pro is an extension to legally cleared device AccuCTP (K220663). AccuCTP Pro is a standalone software package that provides visualization and study of changes of tissue perfusion in digital images captured by CT (Computed Tomography). The software provides viewing, quantification, analysis and reporting capabilities, and it allows repeated use and continuous processing of data and can be deployed on a supportive customer's PC or a virtual platform that meets the minimum system requirements. AccuCTP Pro works with the DICOM compliant medical image data. AccuCTP Pro provides tools for performing the following types of analysis: - Volumetry of threshold maps - Time intensity plots for dynamic time courses - Measurement of mismatch between rCBF and Tmax threshold volumes obtained from the same scan.

AccuFFRangio Plus is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by AccuFFRangio Plus are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.

AccuFFRangio Plus is a system that is used to perform calculations in X-ray angiographic images of the coronary arteries. It includes hardware and software (AccuFFRangio) and the hardware of the device which mainly has a display function and provide the software an operation environment. AccuFFRangio Plus is changed from our own legally marketed predicate device AccuFFRangio that is a stand-alone software package. Therefore, the significant change lies in equipping a computer system to the software on a particular mobile cart.

AcculCAS is software intended to be used for performing calculations in X-ray angiographic images of the intracranial vessels. AcculCAS enables neurointerventionalists to obtain quantifications of one or more lesions in the analyzed intracranial vessel segment. In particular, AccuICAS provides: Quantitative results of intracranial vessel segments based on a 3D reconstructed model; Dimensions of the intracranial vessels and lesions; Quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels. AccuICAS is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of intracranial vessels in X-ray angiographic images. When the quantified results provided by AccuICAS are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.

ArteryFlow AcculCAS is designed as a stand-alone software package to run on a PC. This software can read traditional x-ray angiographic images with DICOM format from the local file directory. AcculCAS is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction and Hemodynamics Calculation for visualization of the target intracranial vessel segment, quantification of morphological parameters and pressure drop of the intracranial vessel segment. AcculCAS is only for quantitative imaging output but not for diagnosis. AcculCAS calculates the pressure gradient (PG) and pressure ratio (PR) value for the intracranial vessel. To obtain these values for a specific lesion in an intracranial vessel, the user needs to start with Frame Selection using the same vessel under different angulation. In each of these images, a classic 2D intracranial vessel contour detection is performed, after which a reconstruction of the intracranial vessel segment is obtained in 3D space. Based on the 3D reconstruction and patients' mean arterial pressure, the corresponding pressure gradient (PG) and pressure ratio (PR) value at each position can be calculated. AcculCAS enables neurointerventionalists to obtain accurate anatomical quantifications of one or more lesions in the analyzed intracranial vessel segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion. AcculCAS's outputs mainly include quantitative dimension results of intracranial vessel and lesions segments based on a 3D reconstructed model and quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels. Besides, other information provided to the end user also belongs to the outputs, such as display of reference vessels and lesions, display of target vessel lumen contour, 3D reconstructed model of intracranial vessels, the diameter stenosis distribution and PG/PR distributions.

AccuCTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices. AccuCTP provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), which can visualize and analyze dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue blood volume.

AccuCTP is a standalone software package that provides visualization and study of changes of tissue perfusion in digital images captured by CT (Computed Tomography). The software provides viewing, quantification, analysis and reporting capabilities, and it allows repeated use and continuous processing of data and can be deployed on a supportive customer's PC that meets the minimum system requirements. AccuCTP works with the DICOM compliant medical image data. AccuCTP provides tools for performing the following types of analysis: - volumetry of threshold maps . - time intensity plots for dynamic time courses . - . measurement of mismatch between rCBF and Tmax threshold volumes obtained from the same scan.

AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures . - Automatic centerline detection - . Visualization of X-ray based images for 2D review and 3D reconstruction - . Placing and sizing tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

The AneuGuide software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally modeling the flow diverters (FD) in the artery to be treated through endovascular surgery. AneuGuide is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area. Also, it allows to pre-operationally estimate the size of flow diverter devices. AneuGuide is composed of the following analysis workflows: image loading, selection of the volume of interest (VOI), segmentation threshold adjustment, reconstruction, selection of the region of interest (ROI), selection of the vessel inlet, generation of centerline, initializing the flow diverter, and sizing the flow diverter. The flow diverter supported by the software is the Pipeline Flex Embolization Device (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, PMA: P100018/S015), which is an FDA-approved neurointerventional device. AneuGuide software has a "moderate" level of concern. It is intended only for preoperational planning. It is not intended for diagnosis.

AccuFFRangio is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by AccuFFRangio are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.

ArteryFlow® AccuFFRangio is designed as a stand-alone software package to run on a PC. This software can read traditional x-ray angiographic images with DICOM format from the local file directory. The AccuFFRangio is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction, QCA Vessel Quantification, and AccuFFRangio Calculation for visualization of the target coronary segment, quantification of the stenosis and pressure drop of the coronary seqment. The AccuFFRangio parameter is only for quantitative imaging output but not for diagnosis and the AccuFFRanigo product has a moderate level of concern. The user can calculate the pressure drop and AccuFFRangio (FFR) value for the coronary vessel. To obtain these values for a specific lesion in a coronary vessel, the user has to start with Frame Selection using two angiographic images from different views. In each of these images, a classic 2D coronary contour detection is performed, after which a reconstruction of the coronary segment is obtained in 3D space. Based on the 3D reconstruction and user input of the aortic pressure, the pressure drop and AccuFFRangio value can be calculated. AccuFFRangio enables interventional cardiologists to obtain accurate anatomical quantifications of one or more lesions in the analyzed coronary segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion during percutaneous coronary intervention (PCI) treatment. Results can be displayed and generated by the software, which contains patient information, imaging of actual and reference vessel boundaries, dimensions of the vessel sizing, pressure drop, and AccuFFRangio value. The results can be export in PDF format. This functionality is independent of the type of vendor acquisition equipment.