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510(k) Data Aggregation

    K Number
    K023988
    Device Name
    GE DISCOVERY LS SYSTEM
    Manufacturer
    GE MEDICAL SYSTEMS
    Date Cleared
    2003-02-04

    (64 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K003849,K000300,K002978,K010641
    Why did this record match?
    Reference Devices :

    K003849, K000300, K002978

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

    The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

    The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation and diagnosis of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This can also assist in radiotherapy planning.

    The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

    Device Description

    The Discovery LS CT-PET System is a combination of the Advance NXi PET Scanner (K003849) and the LightSpeed CT Scanner (K000300, K002978). In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for nonuniform attenuation of the PET images and it uses integrated CT and PET images to localize emission activity in the patient anatomy. Discovery LS has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently reqistered anatomical and functional information via an integrated user interface.

    AI/ML Overview

    The provided 510(k) summary for the GE Discovery LS System does not contain specific acceptance criteria or a detailed study description with performance metrics in numerical form.

    Instead, it states that "Discovery LS bench and clinical data demonstrate the ability of Discovery LS to image injected radiopharmaceuticals for the assessment of metabolic (molecular) and physiologic functions of the body and the ability of Discovery LS to to use integrated CT and PET images to localize metabolic activity and FDG uptake in the patient anatomy." This is a general statement rather than a detailed report of a study designed to meet pre-defined acceptance criteria with quantifiable results.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, MRMC studies, or standalone performance for this specific submission based on the provided text.

    This 510(k) submission focuses on demonstrating substantial equivalence to a previously cleared device (GE CT-PET System K010641) for a revised intended use, rather than presenting a de novo study with explicit performance goals and outcomes.

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