NeuroQuant
NeuroQuant is a medical device with a fully automated Magnetic resonance (MR) imaging post-processing software that provides automatic labeling, visualization, and volumetric quan…
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectrosc…
3D Quorum
Identifies clinically relevant regions of interest through overlapping slices (3mm) to ensure no loss of 3D data. Reduces the number of 3D images to be reviewed by the Radiologist…
TeraRecon iNtuition-Structural Heart Module
The iNtuition-Structural Heart Module is an iNtuition (K121916) based optional feature that employs all standard features offered by iNtuition. These standard features include con…
QVCAD System
QVCAD is designed to process and display a projection image, using the ABUS image stack on a customer supplied computer, and monitor it for review, with certain areas highlighted…
FFRangio
FFRangio analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicia…
Quantra
The Quantra software is designed to estimate breast composition categories by analyzing the distribution and texture of parenchymal tissue patterns, which can be responsible for t…
Surveillance and Reporting of Suicidal Ideation Assessment in PTSD Specialty Care Clinical Notes using Natural Language Processing (NLP)
In light of the known elevated suicide risk among individuals diagnosed and in treatment for mental health conditions, and the associated need for ongoing monitoring of suicidalit…
FastStroke, CT Perfusion 4D
CT perfusion 4D is an image analysis software package, which allows the user to produce dynamic image data and generate information with regards to changes in image intensity over…
Koios
FDA Cleared. Used with Automated Breast Ultrasound (ABUS). Classifies breast ultrasound lesions and automates reporting for improved efficiency and streamlined workflows. Increase…
Discovery MI Gen2
The Discovery MI Gen2 PET/CT system is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It…
Genius AI
Genius AI Detection is a computer-aided detection and diagnosis (CADe/CADx) software device. It is intended to be used with compatible digital breast tomosynthesis (DBT) systems t…
CT CoPilot
CT CoPilot is intended for use in automating post-acquisition quantitative analysis of computed tomography (CT) images of the brain for patients aged 18 or older. CT CoPilot perfo…
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference…
CellaVision DM1200 with the body fluid application
CellaVision DM 1200 with the body fluid application automatically locates and presents images of nucleated cells on cytocentrifuged body fluid preparations. The body fluid applica…
Nediser Reports QA
Nediser is a continuously trained artificial intelligence "radiology resident" that assists radiologists in confirming features in radiology images, including x-ray. It helps with…
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
The CARTO 3 EP Navigation System V8.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter’s location and intracardiac EC…
Care Assessment Needs (CAN) Score
Identify patients at potential risk for 90 day hospitalization and 90 day mortality: CAN 3.0 is a pair of logistic regression models that risk stratify Veterans by their likelihoo…
Cartesion Prime (PCD-1000A/3) V10.15
The system is intended to acquire PET images of any desired region in the whole body and CT images of the same region (used for attenuation correction or image fusion) to detect t…
VA CART SYNTAX Risk Model
The VA CART SYNTAX risk model predicts 30-day post-Percutaneous Coronary Intervention (PCI) mortality, using a combination of clinical and anatomic variables. The model is availab…
Cardiac CT Function Software Application
It is designed to support physicians in the visualization, evaluation, and analysis of the heart function through the calculation of parameters, such as volume and mass. The devic…
Fall Prediction Tool
The Morse Fall Scale (MFS), as it is currently utilized, often fails to accurately assess fall risk, highlighting the need for more precise and timely fall risk assessment tools t…
VA CART Mortality Model
The VA CART mortality risk model is based on logistic regression using baseline clinical and procedural variables to predict post-PCI 30-day mortality. The model is available to f…
VA CART Nephropathy Risk Model
The VA CART nephropathy risk model is based on logistic regression using baseline clinical and procedural variables to predict Post-Percutaneous Coronary Intervention (PCI) acute…