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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.
Heartflow, Inc.
v2.18
In Commercial Distribution
- 00853341006022 ()
- Vascular modelling software
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.
v2.1
In Commercial Distribution
- 00853341006015 ()
- Vascular modelling software
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.
v2.1
In Commercial Distribution
- 00853341006008 ()
- Vascular modelling software
No Description
Disior Oy
1.0
In Commercial Distribution
- 06429810209047 ()
- CAD/CAM software
No Description
Disior Oy
1.0
In Commercial Distribution
- 06429810209030 ()
- CAD/CAM software
Ceevra Reveal 3+ (“Reveal 3+”), manufactured by Ceevra, Inc. (the “Company”), is a software as a medical device with two main functions: (1) it is used by Company personnel to generate three-dimensional (3D) images from existing patient CT and MR imaging, and (2) it is used by clinicians to view and interact with the 3D images during preoperative planning and intraoperatively.
Clinicians view 3D images via the Reveal 3+ Mobile Image Viewer software application which runs on compatible mobile devices, and the Reveal 3+ Desktop Image Viewer software application which runs on compatible computers. The 3D images may also be displayed on compatible external displays, or in virtual reality (VR) format with a compatible off-the-shelf VR headset.
Reveal 3+ includes features that enable clinicians to interact with the 3D images including rotating, zooming, panning, selectively showing or hiding individual anatomical structures, and viewing measurements of or between anatomical structures.
Ceevra, Inc.
3+
In Commercial Distribution
- 00861625000437 ()
- Image segmentation application software
VM11.0 update
Philips Ultrasound LLC
795041
In Commercial Distribution
- 00884838122277 ()
- Radiological PACS software
No Description
Philips Ultrasound LLC
Release 15.6
In Commercial Distribution
- 00884838115323 ()
795041
- Radiological PACS software
No Description
Philips Ultrasound LLC
989605496482
In Commercial Distribution
- 00884838102903 ()
- Radiological PACS software
This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution
- 04547410541199 ()
- Endoscopic video image interpretive software
No Description
Samsung Electronics Co., Ltd.
1.1
In Commercial Distribution
- 08806090792045 ()
- Electrocardiographic monitor
No Description
Samsung Electronics Co., Ltd.
1.1
In Commercial Distribution
- 08806090792021 ()
- Electrocardiographic monitor
No Description
LINKVERSE SRL
4.0.1-S
In Commercial Distribution
- 78055060110375 ()
- 08055060110376 ()
CPRO401S-US
- Endoscopic video image interpretive software
Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution
- 78055060110344 ()
- 08055060110345 ()
CPRO401-US
- Endoscopic video image interpretive software
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution
- 08055060110338 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution
- 08055060110321 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution
- 08055060110314 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
CPRO40.US
In Commercial Distribution
- 78055060110290 ()
- 08055060110291 ()
- Endoscopic video image interpretive software
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution
- 08055060110185 ()
FS01
- Foot-switch, electrical
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution
- 08055060110178 ()
UKS01
- Foot-switch, electrical