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The HeartFlow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for patients with suspected coronary artery disease. It provides anatomic data, plaque identification and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the risk assessment and functional evaluation of coronary artery disease. The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease. The HeartFlow Analysis is intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

The HeartFlow Analysis is an Al-based medical device software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries in the risk stratification and evaluation of coronary artery disease. The software displays coronary and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical workstations.

DEEPVESSEL FFR is a coronary physiological simulation software for the clinical quantitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides DVFFR (a CT-derived FFR measurement) computed from static coronary CTA images using deep learning neural networks that encode imaging, structural, and functional characteristics of coronary arteries through learning. DEEPVESSEL FFR analysis is intended to support the functional evaluation of coronary artery disease. The results of the analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. DEEPVESSEL FFR results are intended to be used by qualified clinicians in conunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

DEEPVESSEL FFR is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It estimates FFR values from static coronary CTA images with extracted coronary tree structures using deep learning neural networks. DEEPVESSEL FFR analysis is intended to support the functional evaluation of CAD. The software processes these images semi-automatically, and it generates a 3D model of the coronay artery tree and computes DVFFR (CT-derived FFR) values. Qualified image analysts interact with the software by providing manual edits to the 3D coronary artery tree segmentations when needed, and oversees outputs along the processing steps. DVFFR analysis results are sent electronically to the physicians via a third-party service portal application. DVFFR software is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation study report includes the specific imaging scanner types and imaging acquisition parameters used in the clinical validation of the product.

The HeartFlow Analysis is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides the calculations of FFR-cf a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the functional evaluation of coronary artery disease. The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The HeartFlow Analysis is intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

The HeartFlow Analysis is a coronary physiological simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with function using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical workstations.

HeartFlow Analysis is a coronary physiologic simulation software for the clinical quantitative and ysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

The HeartFlow Analysis is a coronary physiological simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOMcompliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with function using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment (diagnosis and treatment planning) of coronary artery disease. HeartFlow FFR analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations. The new planner feature is also software, and uses as input the anatomic FFRct model, and an idealized model generated from the FFRct model. Just as a CFD solution is run on the anatomic FFRct model to get the color-coded FFRct Analysis, the planner feature runs a reduced order CFD solution for user selected combinations of the anatomic FFRct model and the idealized model.

HeartFlow FFRct is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRct a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRct analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRct are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

FFRct is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease.

HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

FFRct v2.0 is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with function using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease.

HeartFlow FFRCT is a post-processing software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

FFRc v2.0 is post-processing image analysis software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with function using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease.

HeartFlow FFRcT is a post-processing software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography (CT) DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRcT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRcT analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFR-c are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment. The device is only for prescription use.

FFR v1.4 is post-processing image analysis software developed for the clinical quantitative and qualitative analysis of previously physician-acquired DICOM-compliant cardiac CT images and data, to assess the anatomy and function of the coronary arteries. The software displays the resulting coronary anatomy combined with functional information using graphics and text, including a computed and derived quantification of blood flow. termed FFR - to aid the clinician in the assessment of coronary artery disease. The HeartFlow FFR cr software is housed at Heart Flow, Inc. The health care provider electronically sends the patient's CT scan data to HeartFlow. Inc. where a 3D computer model of the coronary arteries is developed and simulates blood flow in the models using computational fluid dynamics. A resulting report is electronically sent to the physician with the estimated fractional flow reserve (FFR) values (called FFRct values) displayed as color images of the patient's heart (Figure 1) and an associated color interpretation table (Table 1) indicating the error associated with each measurement range in the HFNXT clinical study.