EchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics,EchoPAC Software Only / EchoPAC Plug-in is a software platform designed for diagnostic review, analysis, and reporting of ultrasound images. It allows post-processing of raw data from GE ultrasound scanners and DICOM ultrasound images, supporting multiple clinical applications like fetal, cardiac, abdominal, and musculoskeletal imaging. The software helps clinicians manage patient records and generate detailed reports efficiently.
Intended Use
Intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by or on the order of a licensed physician. Allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Technology
Provides image processing, annotation, analysis, measurement, report generation, communication, storage, and retrieval functionalities. It is DICOM compliant, transferring images and data via LAN, and uses AI algorithms for auto region of interest (ROI) delineation in cardiac function analysis (Easy AutoEF, Easy AFI LV).
Performance
Non-clinical testing showed AI accuracy with average dice scores above 91% across datasets from multiple countries and views. Testing included 45 exams from anonymized patients, with expert cardiologists providing reference standards. Clinical testing was not required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/31/2022
3 months - 2
FDA Approval
7/22/2022
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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