Centricity Universal Viewer
GE HealthcareCentricity Universal Viewer by GE Healthcare is a medical imaging software solution designed to display, manage, analyze, and share medical images from multiple imaging modalities. It facilitates radiologists and cardiologists in interpreting diagnostic images, improving workflow and clinical decision-making. It supports many imaging formats but is not intended for digital pathology diagnosis. The product enhances clinicians' ability to view and interpret images efficiently across healthcare systems.
Intended Use
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and assists in viewing, analysis, diagnostic interpretation, and sharing of images and information by authorized healthcare professionals.
Technology
Centricity Universal Viewer is an internet-based medical image display and interpretation software within a PACS framework. It integrates with diverse DICOM imaging modalities and uses APIs for 3rd-party device integration. The system operates over TCP/IP networks on standard computer platforms and does not generate original images; it receives DICOM-compliant images for processing and display.
Performance
The device underwent extensive non-clinical testing including software verification, validation of user needs, regression testing, integration, interoperability testing, usability testing, and cybersecurity analysis. It follows FDA software submission guidance for moderate risk devices. No animal or biological testing was necessary. The modifications do not impact safety or effectiveness, confirming equivalency to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/5/2018
3 months - 2
FDA Approval
12/14/2018
Other devices from GE Healthcare
- Precision DL2023 • 510K
- Xeleris V Processing and Review System2023 • 510K
- Voluson P6, Voluson P82022 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.