GE Medical Systems SCS radiology AI products

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Do related FDA submissions document the same scope, or different functions and versions?
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Radiology AI pricing and total cost of ownership

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FDA-cleared K243672

CardIQ Suite

GE Medical Systems SCS

Authorized purpose: 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, and treatment or follow-up support under clinician review.

Modality: CT/CTA
Anatomy: Heart/Cardiovascular
Decision: 2025-06-18

Cardiac imaging Quantification and segmentation

FDA-cleared K243651

VersaViewer

GE Medical Systems SCS

Authorized purpose: VersaViewer supports two-dimensional, three-dimensional, and four-dimensional medical-image series processing and analysis through customizable layouts, multimodality review, and measurements for trained healthcare professionals; it is not for displaying digital mammography for diagnosis.

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

Breast imaging Quantification and segmentation

FDA-cleared K243446

3DXR

GE Medical Systems SCS

Authorized purpose: 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

Fluoroscopy/Angiography workflow

FDA-cleared K233731

CardIQ Suite

GE Medical Systems SCS

Authorized purpose: Cardiac CT visualization, measurement, segmentation, tracking, labeling, and calcium scoring to support review of cardiovascular anatomy and pathology, coronary artery disease, and treatment-path decisions.

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

Cardiac imaging Quantification and segmentation

FDA-cleared K223424

Spine Auto Views

GE Medical Systems SCS

Authorized purpose: 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 predetermined DICOM destinations for review.

Modality: CT/CTA
Anatomy: Spine
Decision: 2023-07-13

MSK and bone

FDA-cleared K223490

FlightPlan for Embolization

GE Medical Systems SCS

Authorized purpose: Post-processes 3D X-ray angiography to help physicians visualize vasculature during embolization planning.

Modality: CBCT
Anatomy: Vasculature throughout the body
Decision: 2023-03-21

CBCT workflow

FDA-cleared K213725

CardIQ Suite

GE Medical Systems SCS

Cardiac CT software for visualization, measurement, and calcium scoring to support clinician-led cardiovascular assessment.

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

Cardiac imaging Quantification and segmentation

FDA-cleared K210807

FlightPlan for Liver

GE Medical Systems SCS

Authorized purpose: Visualizes hepatic vasculature and identifies arteries near hypervascular liver lesions during planning of liver embolization.

Modality: Fluoroscopy/Angiography
Anatomy: Liver; hepatic arterial vasculature and hypervascular liver lesions
Decision: 2021-10-22

Oncology quantification

FDA-cleared K193306

PROView

GE Medical Systems SCS

Authorized purpose: 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 visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians.

Modality: MRI
Anatomy: Prostate
Decision: 2020-11-17

Prostate imaging Quantification and segmentation

FDA-cleared K193289

FastStroke, CT Perfusion 4D

GE Medical Systems SCS

Authorized purpose: Analyzes CT data to display head and neck vasculature and CT perfusion to generate regional blood-flow, blood-volume, mean-transit-time, and capillary-permeability images.

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-11-12

CT/CTA workflow

FDA-cleared K193281

Hepatic VCAR

GE Medical Systems SCS

Authorized purpose: 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 distribute liver CT studies.

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

Oncology quantification Quantification and segmentation

FDA-cleared K183204

Bone VCAR (BVCAR)

GE Medical Systems SCS

Authorized purpose: CT post-processing for spine review, labeling, display optimization, and report dictation.

Modality: CT/CTA
Anatomy: Spine
Decision: 2019-04-08

MSK and bone

FDA-cleared K133649

HEPATIC VCAR

GE MEDICAL SYSTEMS SCS

Authorized purpose: 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 confirm.

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

Oncology quantification Quantification and segmentation