HeartFlow Analysis

GUDID 00853341006039

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.

HEARTFLOW, INC.

Vascular modelling web-based application software
Primary Device ID00853341006039
NIH Device Record Keye9515eb4-e12c-4884-acaf-a8ec52aad9c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartFlow Analysis
Version Model NumberFFRct version 2
Company DUNS804411283
Company NameHEARTFLOW, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com
Phone+16502410500
Emailsupport@heartflow.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853341006039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PJACoronary Vascular Physiologic Simulation Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-16
Device Publish Date2020-04-08

On-Brand Devices [HeartFlow Analysis]

00853341006039The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical qu
00853341006053The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical qu

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