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510(k) Data Aggregation

    K Number
    K022960
    Date Cleared
    2002-09-19

    (13 days)

    Product Code
    Regulation Number
    892.1200
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    GE QUASAR NUCLEAR MEDICINE SYSTEM

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

    The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncolgy, Cardiology, Neurology and other clinical diagnostic imaging applications.

    The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT . Gated SPECT . Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multiisotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation corrcction and functional anatomic mapping.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for the GE Quasar System, a nuclear medicine imaging system. It details the device's name, submitter, classification, and intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment, sample sizes, or expert qualifications.

    Therefore, I cannot provide the requested information based on the given document.

    The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices for the purpose of FDA clearance. It does not include the detailed performance study results that would typically contain acceptance criteria and performance metrics.

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