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CardNav, an image acquisition and processing modular software package, is indicated for use as follows: Assist in projection selection using 3D modeling based on 2D images. Perform quantitative analysis on coronary veins based on fluoroscopy images. Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy. Perform motion analysis on coronary veins based on fluoroscopy images. To be used in cardiac procedures and off-line for post-procedural analysis.

CardNav (version 1.0) is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. It enhances the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning and therapeutic staging. This data is obtained without altering the basic angiography procedure.

C-THV, an image acquisition and processing modular software package, is indicated for use as follows: - Assists in projection selection using 3D modeling based on 2D images - Performs dimensional measurements based on DICOM images. - Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy. The system is to be used in-procedure and off-line for post-procedural analysis.

The C-THV (version 4.6) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system enhances the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic staging and post deployment analysis. The C-THV provides quantitative data of vessel and localizes device on predefined roadmaps. The C-THV is intended to be used in patients with vascular, congenital, valvular, and myopathic heart disease as well as with patients undergoing artificial valve deployment. The C-THV package includes and elaborates on previously developed, 510(k) cleared, and marketed modules of IC-PRO (version 3.5, model B) system. It comprised of the following modules: 1. Optimal Projection 2. Dimensional Measurements 3. Virtual Valve 4. Positioning

IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows: Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. Performs quantitative analysis of the left ventricle based on left ventricular angiograms. Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings Assist in device positioning by providing real time localization on predefined roadmaps. Assists in projection selection using 3D modeling based on 2D images. Performs dimensional measurements based on DICOM images. To be used in-procedure in the catheterization lab and off-line for post-procedural analysis

The IC-PRO (version 3.5, model B) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic stage and post deployment analysis. The IC-PRO provides quantitative data and vessel measurements, left ventricular, stent dimensions, enhances visualization, localizes device on predefined roadmaps and assist in projection selection. The IC-PRO is used in patient with vascular, congenital, valvular, and myopathic heart disease and patients undergoing vascular stenting and artificial valve deployment.

IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows: 1. Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. 2. Performs quantitative analysis of the left ventricle based on left ventricular angiograms. 3. Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings 4. Assist in device positioning by providing real time localization on predefined roadmaps. 5. To be used in-procedure in the catheterization lab and off-line for post-procedural analysis

The IC-PRO (version 3.2) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic stage and post deployment analysis. IC-PRO (version 3.2) provides quantitative data of vessel, left ventricular and stent dimensions enhances visualization and localizes device on predefined roadmaps.

IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows: - Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. - Performs quantitative analysis of the left ventricle based on left ventricular angiograms. - Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings - To be used in-procedure in the catheterization lab and off-line for postprocedural analysis

The IC-PRO System is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning and post deployment analysis. IC-PRO enhances visualization and provides quantitative data of vessel, left ventricular and stent dimensions.

The CardiOp-B System is a software system that assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B can also perform quantitative analysis of the left ventricle based on left ventricular angiograms. CardiOp-B is intended for use in real-time in the catheterization lab and off-line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel.

The CardiOp-B System is an image acquisition and processing software system designed as an add-on to conventional X-ray angiography systems. The CardiOp-B system improves the output of coronary angiography by presenting a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The LVA (Left Ventricular Analysis) package is an addition to the CardiOp-B System which is the subject of this Traditional 510(K).

The CardiOp-B System is a software system that assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B is intended for use in real-time in the catheterization lab and off-line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel.

The CardiOp-B System is an image acquisition and processing software system designed as an add-on to conventional X-ray angiography systems. The CardiOp-B system improves the output of coronary angiography by presenting a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The modifications to the CardiOp-B System which are the subject of this Special 510(K) include: Bifurcation and side-branch analysis

The CardiOp-B System is a software system that assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single Segments based on CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B is intended for use in real-time in the catheterization lab and offline for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel

The CardiOp-B System is an image acquisition and processing software system designed as an add-on to conventional X-ray angiography systems. The CardiOp-B system presents a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The system includes a software package that runs on off-the-shelf hardware. CardiOp-B's features and benefits include 3D reconstruction, real-time and quantitative measurements.