EchoPAC Software Only, EchoPAC Plug-In
GE Medical Systems Ultrasound and Primary Care DiagnosticsEchoPAC Software Only / EchoPAC Plug-in is a diagnostic ultrasound image analysis software by GE that enables physicians to view, post-process, measure, and analyze ultrasound images across many clinical applications including cardiac, fetal, abdominal, musculoskeletal, and vascular imaging. It incorporates AI-based features to semi-automate cardiac measurements and streamline image interpretation, helping clinicians obtain quantitative data more efficiently and accurately.
Intended Use
Diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by licensed physicians. Allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Technology
Software provides image processing, annotation, analysis, measurement, report generation, communication, storage, and retrieval functionality for ultrasound images from GE Vivid scanners and other vendors. Includes AI features for cardiac auto measurement and spectrum recognition based on prior cleared technologies. DICOM compliant and able to transfer images via LAN.
Performance
The software underwent non-clinical performance verification and validation such as risk analysis, unit and system testing, usability, and compliance with applicable standards. No clinical studies were required as substantial equivalence to predicate devices was demonstrated.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/31/2020
5 months - 2
FDA Approval
9/18/2020
Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics
- Vivid Pioneer2025 • 510K
- Versana Premier; Versana Premier Lotus; LOGIQ F2024 • 510K
- Voluson Signature 20, Voluson Signature 182024 • 510K
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