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…
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.
Who Else Makes It
Registered in Beijing.
Record
Regulatory record for FFRct | Listed by | Heartflow, Inc., United States |
| FDA product code | PJA |
| Device type | Coronary Vascular Physiologic Simulation Software |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1415 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K161772 |
| Record published | 2016-12-06 |
| Record revised | 2022-12-21 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.