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GE HealthCare AI Solutions

by GE HealthCare

AI Application
Low Confidence

GE HealthCare tops the FDA's public list of AI-enabled medical device authorizations with 110+ cleared/authorized devices. Its AI/software portfolio includes CareIntellect (integrated care applications), Command Center (hospital operations orchestration), PACS & AI Orchestration, Verisound (digital & AI ultrasound), Genesis Solutions, AW Advanced Visualization, and Enterprise Imaging/Datalogue. Functions span AI-assisted image reconstruction/enhancement, clinical decision support, workflow automation, and predictive hospital operations analytics across CT, MRI, ultrasound, and X-ray modalities.

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Transparency Score

Weighted across four pillars · updated September 3, 2026

Overall grade
46% weighted
ABCDF
Model
—
Not yet assessed
Infrastructure
—
Not yet assessed

Capabilities

Ai Image Reconstruction
Clinical Decision Support
Hospital Operations Orchestration
Predictive Hospital Analytics
Diagnostic Ai
Workflow Automation

Vendor Information

Complete information about the vendor/provider of this AI application

GE HealthCareView all products →
GE HealthCare(Trading as: General Electric)
Contact Information
www.gehealthcare.com
+18004371171
Registered Address
1 N State St, Chicago, IL 60602, US

EU AI Act Provider Information

Verification Status:
Partially Verified
(Last verified: September 3, 2026)
GE HealthCare(Trading as: General Electric)
1 N State St, Chicago, IL 60602, US
+18004371171
GE Healthcare International Benelux B.V. / GE Healthcare B.V.
De Rondom 8, Eindhoven, NL
Compliance Documents
CE Marking: Not Applicable
Maintains a dedicated Adverse Event Reporting channel and an Expanded Access Policy for investigational products, consistent with FDA post-market surveillance obligations for medical devices.
As an FDA-regulated medical device manufacturer, GE HealthCare's AI-enabled devices operate under formal software-as-a-medical-device (SaMD) regulatory frameworks with defined intended use, indications, and limitations per individual FDA clearance/authorization -- these vary by specific product and are documented in each device's labeling rather than at the company level.

Potential Risks

1 considerations identified

1

Review recommended before use

These considerations are automatically identified based on publicly available information about the vendor and AI catalog data. Actual risks may vary based on your specific use case and implementation.

Compliance & Risk

Get insights into risk by running assessments on this AI application.

Work at GE HealthCare? Claim this listing to correct or complete the data.

Added: September 3, 2026
Updated: September 3, 2026

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