FDA.report

Vascular modelling web-based application software

Definition
An 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.
GUDID devices
17
Last updated
2021-06-16 06:29:14

Related Product Codes

CodeDeviceSpecialtyClassDevices
PZOSoftware For Visualization Of Vascular Anatomy And Intravascular DevicesRadiology212
PJACoronary Vascular Physiologic Simulation SoftwareCardiovascular25

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00853341006053HeartFlow AnalysisHEARTFLOW, INC.FFRct version 32021-06-08
00853341006039HeartFlow AnalysisHEARTFLOW, INC.FFRct version 22020-04-08
B642SURGICALPREVIEW3200SurgicalPreviewENDOVANTAGE LLC3.3.02019-11-27
B642SURGICALPREVIEW3100SurgicalPreviewENDOVANTAGE LLC3.2.02019-11-05
B642SURGICALPREVIEW3000SurgicalPreviewENDOVANTAGE LLC3.1.02019-10-23
B642SURGICALPREVIEW2600SurgicalPreviewENDOVANTAGE LLC3.0.02019-09-12
B642SURGICALPREVIEW2500SurgicalPreviewENDOVANTAGE LLC2.6.02019-06-07
B642SURGICALPREVIEW2400SurgicalPreviewENDOVANTAGE LLC2.5.02019-04-30
B642SURGICALPREVIEW100SurgicalPreviewENDOVANTAGE LLC1.02018-04-06
B642SURGICALPREVIEW1100SurgicalPreviewENDOVANTAGE LLC1.1.02018-04-16
B642SURGICALPREVIEW1200SurgicalPreviewENDOVANTAGE LLC1.2.02018-04-29
B642SURGICALPREVIEW2100SurgicalPreviewENDOVANTAGE LLC2.2.02018-12-07
B642SURGICALPREVIEW2200SurgicalPreviewENDOVANTAGE LLC2.3.02019-01-28
B642SURGICALPREVIEW2300SurgicalPreviewENDOVANTAGE LLC2.4.02019-02-07
00853341006008FFRctHEARTFLOW, INC.v2.12016-08-01
00853341006015FFRctHEARTFLOW, INC.v2.12016-12-06
00853341006022FFRctHEARTFLOW, INC.v2.182019-02-01