FFRct

GUDID 00853341006008

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.

HEARTFLOW, INC.

Vascular modelling web-based application software
Primary Device ID00853341006008
NIH Device Record Key8f00a9e7-4fb5-431f-a163-2ebf1b6f6f5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFFRct
Version Model Numberv2.1
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 Perscriptionfalse
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
GS100853341006008 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-08-01

On-Brand Devices [FFRct]

00853341006022HeartFlow FFRct is coronary physiologic simulation software developed for the clinical quantitat
00853341006015HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualit
00853341006008HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualit

Trademark Results [FFRct]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FFRCT
FFRCT
90808627 not registered Live/Pending
Elucid Bioimaging Inc.
2021-07-02
FFRCT
FFRCT
85334348 not registered Dead/Abandoned
Heartflow, Inc.
2011-05-31
FFRCT
FFRCT
85284255 4641484 Dead/Cancelled
Heartflow, Inc.
2011-04-01

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