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| Product | Model | Company | Device type |
|---|---|---|---|
| Product | Model | Company | Device type |
|---|---|---|---|
HeartFlow 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. FFRct is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation report includes identification of vendors and equipment used in the clinical validation of the product. This data is summarized in the product labeling, and can be found in the Clinical User Instructions for Use. HeartFlow FFRct analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
| Product | Model | Company | Device type |
|---|---|---|---|
| FFRctHeartflow, Inc.Vascular modelling software | v2.1 | Heartflow, Inc. | Vascular modelling software |
| HeartFlow AnalysisHeartflow, Inc.Vascular modelling software | FFRct version 3 | Heartflow, Inc. | Vascular modelling software |
| FFRangioCathworks LtdDiagnostic x-ray digital imaging system workstation | FAU01000 | Cathworks Ltd | Diagnostic x-ray digital imaging system workstation |
| FFRangioCathworks LtdDiagnostic x-ray digital imaging system workstation | FAU04000 | Cathworks Ltd | Diagnostic x-ray digital imaging system workstation |