HeartFlow Analysis

Primary DI
00853341006060
Brand
HeartFlow Analysis
Company
Heartflow, Inc.
Model
FFRct version 3
Device description
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.
Published
2022-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
PJACoronary Vascular Physiologic Simulation Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
PJACoronary Vascular Physiologic Simulation SoftwareCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213857000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213857000HeartFlow AnalysisHeartFlow, Inc.2022-10-14PJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853341006060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853341006060008533410060608533410060600853341006060

GMDN Terms#

Term, Definition table
TermDefinition
Vascular modelling softwareA stand-alone software application 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. It is designed to be installed on an off-the-shelf computer/smart device.

Contacts#

Phone, Email table
PhoneEmail
6502410500support@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
00853341006053HeartFlow AnalysisFFRct version 32021-06-08
00853341006039HeartFlow AnalysisFFRct version 22020-04-08
00853341006008FFRctv2.12016-08-01
00853341006015FFRctv2.12016-12-06
00853341006022FFRctv2.182019-02-01

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