heartflow.comHeartFlow Analysis
HeartFlow, Inc.
HEARTFLOW, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3021637148 | 3021637148 | HEARTFLOW, INC. | 1 | N | 2026-01-01 | 135 Main St Ste 1000 San Francisco CA US 94105 |
| 3011276938 | 3011276938 | HEARTFLOW, INC. | 1 | N | 2020-04-25 | 1400 Seaport Blvd Bldg B Redwood City CA US 94063 |
| 3014894404 | 3014894404 | HeartFlow, Inc. | 1 | N | 2020-04-25 | 4516 Seton Center Parkway, Suite 200 Austin TX US 78759 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00853341006008 | FFRct - HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography 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 independent of imaging equipment, imaging protocols and equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and workstations. | +16502410500 | support@heartflow.com |
| 00853341006015 | FFRct - HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis ofpreviously acquired Computed Tomography DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images anddata, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functionalinformation using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid theclinician in the assessment of coronary artery disease. HeartFlow FFRct is independent of imaging equipment, imaging protocolsand equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated toacquisition equipment and workstations. | +16502410500 | support@heartflow.com |
| 00853341006022 | FFRct - 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. | +16502410500 | support@heartflow.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 302618 | 1357709672 | K250902 | HeartFlow Analysis | PJA | 2025-07-18 |
| 302618 | 1068292366 | K213857 | HeartFlow Analysis | PJA | 2022-10-14 |
| 302618 | 1634353529 | K203329 | HeartFlow Analysis | PJA | 2021-01-08 |
| 177661 | 1715924106 | K190925 | HeartFlow FFRct Analysis | PJA | 2019-08-15 |
| 221646 | 1715924106 | K190925 | HeartFlow FFRct Analysis | PJA | 2019-08-15 |
| 177661 | 1467585357 | K182035 | FFRct | PJA | 2018-12-06 |
| 221646 | 1467585357 | K182035 | FFRct | PJA | 2018-12-06 |
| 177661 | 1395421611 | K161772 | FFRct | PJA | 2016-08-24 |
| 221646 | 1395421611 | K161772 | FFRct | PJA | 2016-08-24 |
| 177661 | 1380481105 | K152733 | FFRct | PJA | 2016-01-13 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PJA | 10 | 2025-07-18 |
PMN#
HeartFlow Analysis
HeartFlow, Inc.
HeartFlow Analysis
HeartFlow, Inc.
HeartFlow FFRct Analysis
HeartFlow, Inc.
FFRct
HeartFlow, Inc
FFRct
HEARTFLOW, INC.
FFRct
HEARTFLOW, INC.
GUDID#
Heartflow Analysis - 4.x
2025-09-20
HeartFlow Analysis - The HeartFlow Analysis is AI-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 anatomy 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 are unrelated to acquisition equipment and clinical workstations.
2022-12-21
HeartFlow Analysis - The HeartFlow Analysis 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 and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
2021-06-08
HeartFlow Analysis - The HeartFlow Analysis 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 and treatment planning of coronary artery disease.The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
2020-04-08
FFRct - HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography 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 independent of imaging equipment, imaging protocols and equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and workstations.
2016-08-01
FFRct - HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis ofpreviously acquired Computed Tomography DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images anddata, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functionalinformation using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid theclinician in the assessment of coronary artery disease. HeartFlow FFRct is independent of imaging equipment, imaging protocolsand equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated toacquisition equipment and workstations.
2016-12-06
FFRct - 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.
2019-02-01