LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120221
    Device Name
    GE ECHOPAC
    Manufacturer
    GE HEALTHCARE
    Date Cleared
    2012-03-30

    (65 days)

    Product Code
    LLZ,K10
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K101324
    Why did this record match?
    Reference Devices :

    K101324

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

    The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

    Device Description

    GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family ultrasound scanners, primarily for cardiology ultrasound of applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the postacquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. EchoPAC is DICOM compliant. transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC are substantially equivalent to the predicate device and functionality cleared on GE EchoPAC K101324.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. Specifically, it states:

    "The subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence."

    Instead, the document focuses on establishing substantial equivalence to a predicate device (K101324 - GE EchoPAC) based on similar technology and non-clinical tests for conformance to design specifications and industry standards.

    Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert opinions, or comparative effectiveness studies, as this information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1