FDA-cleared K243672

CardIQ Suite

GE Medical Systems SCS

CardIQ Suite analyzes 2D or 3D cardiac CT DICOM data for visualization and measurement of cardiovascular anatomy, coronary calcium scoring, coronary review, heart-fat estimation,...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2025-06-18
FDA-cleared K243651

VersaViewer

GE Medical Systems SCS

VersaViewer supports two-dimensional, three-dimensional, and four-dimensional medical-image series processing and analysis through customizable layouts, multimodality review, and...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region anatomy represented in CT, MR, PET, NM, XA, and other supported studies
Decision
2025-04-21
FDA-cleared K243446

3DXR

GE Medical Systems SCS

3DXR reconstructs cone-beam CT from interventional X-ray acquisitions and uses CleaRecon DL to reduce streak artifacts for display in the advanced workstation workflow.

Modality
Fluoroscopy/Angiography
Anatomy
Multi-region
Decision
2025-02-25
FDA-cleared K233731

CardIQ Suite

GE Medical Systems SCS

Cardiac CT visualization, measurement, segmentation, tracking, labeling, and calcium scoring to support review of cardiovascular anatomy and pathology, coronary artery disease,...

Modality
CT/CTA
Anatomy
Heart and cardiovascular structures, including coronaries, chambers, vessels, valves, and aorta
Decision
2024-08-01
FDA-cleared K223424

Spine Auto Views

GE Medical Systems SCS

Use with CT images to automatically generate anatomically focused multi-planar spine reformats, apply vertebral-body and intervertebral-disc labels, and export the results to...

Modality
CT/CTA
Anatomy
Spine
Decision
2023-07-13
FDA-cleared K213725

CardIQ Suite

GE Medical Systems SCS

Visualization and measurement of cardiovascular anatomy, chamber mobility, calcium scoring, and follow-up of stents, bypasses, and plaque imaging to aid diagnosis and...

Modality
CT/CTA
Anatomy
Heart and cardiovascular anatomy, including vessels, chambers, coronary arteries, heart valves, and great vessels such as the aorta.
Decision
2022-03-11
FDA-cleared K210807

FlightPlan for Liver

GE Medical Systems SCS

FlightPlan for Liver is a post processing software package that helps the analysis of 3D x-ray angiography images of the liver. Its output is intended as an adjunct means to help...

Modality
Fluoroscopy/Angiography
Anatomy
Liver
Decision
2021-10-22
FDA-cleared K193306

PROView

GE Medical Systems SCS

PROView is an aiding tool for the clinicians to review multi-parametric prostate MR images following PI-RADS guidelines. It displays acquired and reformatted data for...

Modality
MRI
Anatomy
Prostate
Decision
2020-11-17
FDA-cleared K193289

FastStroke, CT Perfusion 4D

GE Medical Systems SCS

FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-11-12
FDA-cleared K193281

Hepatic VCAR

GE Medical Systems SCS

Analysis and visualization of liver CT data from DICOM 3.0-compliant CT scans to assess liver morphology and lesion change over time and to process, review, archive, print, and...

Modality
CT/CTA
Anatomy
Liver, liver lobes, liver segments, liver lesions, and hepatic artery
Decision
2020-03-20
FDA-cleared K183204

Bone VCAR (BVCAR)

GE Medical Systems SCS

Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by...

Modality
CT/CTA
Anatomy
Spine
Decision
2019-04-08
FDA-cleared K133649

HEPATIC VCAR

GE MEDICAL SYSTEMS SCS

Hepatic VCAR analyzes CT liver images to assess liver morphology and liver lesions with automated liver, lobe, segment, lesion, and measurement tools that a clinician can edit and...

Modality
CT/CTA
Anatomy
Liver
Decision
2014-04-22