FFRct

Primary DI
00853341006022
Brand
FFRct
Company
Heartflow, Inc.
Model
v2.18
Device description
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.
Published
2019-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJACoronary Vascular Physiologic Simulation Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJACoronary Vascular Physiologic Simulation SoftwareCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182035000FFRctHeartFlow, Inc.2018-12-06PJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853341006022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853341006022008533410060228533410060220853341006022

GMDN Terms#

Term, Definition table
TermDefinition
Vascular modelling web-based application softwareAn application software program intended to aid assessment of vascular stenosis and/or endovascular interventions, by producing a three-dimensional (3-D) cardiovascular model which has features of predicted blood flow data and/or endovascular device deployments. It typically uses computed tomography (CT) images and may be intended as an alternative to invasive techniques (i.e., invasive blood pressure, invasive fractional flow reserve, angiography); it is not intended to store patient records.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16502410500support@heartflow.com

Regulatory Flags#

DUNS number
804411283
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853341006701Heartflow Analysis4.x2025-09-20
00853341006060HeartFlow AnalysisFFRct version 32022-12-21
00853341006053HeartFlow AnalysisFFRct version 32021-06-08
00853341006039HeartFlow AnalysisFFRct version 22020-04-08
00853341006008FFRctv2.12016-08-01
00853341006015FFRctv2.12016-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974636510087DEEPVESSELKeya Medical Technology Co., Ltd.PJA2025-12-22
00853341006701Heartflow AnalysisHeartflow, Inc.PJA2025-09-20
00853341006060HeartFlow AnalysisHeartflow, Inc.PJA2022-12-21
00853341006053HeartFlow AnalysisHeartflow, Inc.PJA2021-06-08
00853341006039HeartFlow AnalysisHeartflow, Inc.PJA2020-04-08
00853341006015FFRctHeartflow, Inc.PJA2016-12-06
00853341006008FFRctHeartflow, Inc.PJA2016-08-01