445 matching use cases
Federal Government ×High ×
OMB-IND-VA-24-5140OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5169OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5173OMB Individually Reported

Implementation of a Severe COVID-19 Risk Prediction Tool

OMB Individually ReportedHigh risk
OMB-IND-VA-24-5181OMB Individually Reported

CVI42

OMB Individually ReportedHigh risk
OMB-IND-VA-24-5222OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5263OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5333OMB Individually Reported

Aquilion ONE with AiCE

OMB Individually ReportedHigh risk
OMB-IND-VA-24-540OMB Individually Reported

ECG/EKG Machines- Interpretation of Results

OMB Individually ReportedHigh risk
OMB-IND-VA-24-5427OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-544OMB Individually Reported

Appointment Comments Categorization

OMB Individually ReportedHigh risk
OMB-IND-VA-24-5464OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5468OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5501OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5509OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5542OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5579OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5583OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5620OMB Individually Reported

Pact Act Co-Pay Exemption Prediction Tool

OMB Individually ReportedHigh risk
OMB-IND-VA-24-5624OMB Individually Reported

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…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5632OMB Individually Reported

Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

Brainlab Elements are software applications indicated for the processing of medical image data to support the intended user group to perform image guided surgery and radiation tre…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5714OMB Individually Reported

BioPlex 2200 ANA Screen with Medical Decision Support Software for Use with BioPlex 2200 Multi-Analyte Detection System

The BioPlex 2200 Medical Decision Support Software (MDSS) is a pattern recognition algorithm that can enhance the performance of the Antinuclear Antibody (ANA) Screening associate…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-573OMB Individually Reported

GE AMX Portable X-ray Machines

OMB Individually ReportedHigh risk
OMB-IND-VA-24-5788OMB Individually Reported

VA CART Bleeding Risk Model

The VA CART bleeding risk model is based on logistic regression, using baseline clinical and procedural variables to predict post-Percutaneous Coronary Intervention (PCI) in-hospi…

OMB Individually ReportedHealth and MedicalHigh risk
OMB-IND-VA-24-5796OMB Individually Reported

Biograph Vision, Biograph MCT Family Of PET/CTs

The Biograph Vision and Biograph mCT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (Po…

OMB Individually ReportedHealth and MedicalHigh risk