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510(k) Data Aggregation

    K Number
    K251342
    Device Name
    EchoPAC Software Only / EchoPAC Plug-in
    Manufacturer
    GE Medical Systems Ultrasound and Primary Care Diagnostics
    Date Cleared
    2025-07-16

    (77 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K220940
    Why did this record match?
    Reference Devices :

    EchoPAC Software Only / EchoPAC Plug-in (K200852), EchoPAC Software Only / EchoPAC Plug-in (K170847),

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EchoPAC Software Only / EchoPAC Plug-in is 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. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

    Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).

    Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.

    Device Description

    EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.

    AI/ML Overview

    The provided 510(k) clearance letter and summary discuss the EchoPAC Software Only / EchoPAC Plug-in, including a new "AI Cardiac Auto Doppler" feature. The acceptance criteria and the study proving the device meets these criteria are primarily detailed for this AI-driven feature.

    Here's an organized breakdown of the information:

    1. Acceptance Criteria and Reported Device Performance (AI Cardiac Auto Doppler)

    Acceptance CriteriaReported Device Performance
    Feasibility score of more than 95%The verification requirement included a step to check for a feasibility score of more than 95%. (Implies this was met for the AI Cardiac Auto Doppler).
    Expected accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter.The verification requirement included a step to check mean percent absolute error across all cardiac cycles against a threshold. All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. These results indicate that observed accuracy of each of the individual clinical parameters met the acceptance criteria.
    For Tissue Doppler performance metric: Threshold not explicitly stated, but comparative values for BMI groups are provided.**BMI
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