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Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Autoplaque is a workstation-based post processing application. It is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present. Autoplaque must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Autoplaque 3.0. a stand-alone software, performs post-processing of coronary Computed Tomography Angiography (CTA) images and measurements of components of images using computerized algorithms. Autoplaque 3.0 aids the physician with measurement of coronary artery stenosis and provides measurements for coronary plaque and coronary artery remodeling. Autoplaque 3.0 does not replace standard clinical practice or clinician decision making. Autoplaque 3.0 allows for standardized characterization of plaque and stenosis from DICOM image data (loaded from the local computer hard drive) and includes the following features: - Review of heart and coronary vessels in Multiplanar Reformatting (MPR), curved MPR, and straightened MPR views: - Measurement of vessel diameter and area; - Characterization and measurement of plaque parameters; and - Measurement of lumen diameter, area, and luminal stenosis. Autoplaque 3.0 includes automated vessel, plaque and lumen segmentation, which is reviewed and can be edited, if necessary, by the clinician. Autoplaque 3.0 can run on Windows or Mac computer platforms. The minimum hardware specifications are specified in the user manual.

The Cedars-Sinai Cardiac Suite of applications is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. Cedars-Sinai Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Indication/Intended Use and the fundamental scientific technology of the modified device has not been changed and the same as those described in the unmodified predicate device. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QPS+QGS (Quantitative Perfusion SPECT + Ouantitative Gated SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), ARG/QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO), Automated Reconstruction (AutoRECON), CSView (Cedars-Sinai Viewer) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.

The Cedars-Sinai Cardiac Suite of applications is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. Cedars-Sinai Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. Cedars-Sinai Cardiac Suite (non-viewer) minimum system requirements include a computer with at least IGB RAM, 50MB hard disk space for software installation. a display resolution of at least 1024x768 with 16-bit color, a network adapter, a mouse (or other pointer device; trackpad, trackball, etc ... ) and one of the following operating systems: Windows XP, Windows Vista, Windows 7, Windows 8, Windows Server 2003. Windows Server 2008. Windows Server 2012. Mac OS X (10.6. 10.7 & 10.8). The viewer component of the Cedars-Sinai Cardiac Suite minimum system requirements is iPad 2, iPad (3rd generation), iPad (4th generation) and iPad Mini. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QPS+QGS (Quantitative Perfusion SPECT + Quantitative Gated SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quanitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO), Automated Reconstruction (AutoRECON), Remote Viewer (Viewer) and OPET. OPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.

The CSMC Cardiac Suite is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. CSMC Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. Cedars-Sinai Cardiac Suite minimum system requirements include a computer with at least 1GB RAM, 50MB hard disk space for software installation, a display resolution at least 1024x768 with 16-bit color, a network adapter, a mouse (or other pointer device; trackpad, trackball, etc.) and one of the following operating systems: Windows XP Professional. Windows Vista Professional. Windows 7 Professional. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.