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510(k) Data Aggregation

    K Number
    K003241
    Device Name
    ECAT PET SCANNER
    Manufacturer
    CTI PET SYSTEMS, INC.
    Date Cleared
    2000-12-13

    (57 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ECAT PET SCANNER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K002715
    Device Name
    ECAT PET SCANNER
    Manufacturer
    CTI PET SYSTEMS, INC.
    Date Cleared
    2000-10-31

    (61 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ECAT PET SCANNER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K002039
    Device Name
    ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART
    Manufacturer
    CTI PET SYSTEMS, INC.
    Date Cleared
    2000-09-27

    (84 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K974256
    Device Name
    ECAT PET SCANNERS
    Manufacturer
    CTI PET SYSTEMS, INC.
    Date Cleared
    1998-02-25

    (104 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ECAT PET SCANNERS

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

    Siemens/CPS ECAT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

    ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner.

    Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method for measuring the attenuation effect of the body on the tracer radiation being detected and imaged. Attenuation correction is utilized to enable quantitative interpretation of the acquired emission data.

    Device Description

    Software version 7.1 and Single Photon Detection Transmission Scan System for ECAT PET Scanners. ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner. Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method for measuring the attenuation effect of the body on the tracer radiation being detected and imaged.

    AI/ML Overview

    The provided text, primarily a 510(k) clearance letter and an "Indications For Use" statement, does not contain the specific details about acceptance criteria, device performance results, or a detailed description of a clinical study as requested.

    The document indicates that the device (ECAT Pet Scanner System and Software Version 7.1) was found substantially equivalent to a predicate device, allowing it to be marketed. However, it does not provide the technical performance data that would typically be included in a study report.

    Therefore, I cannot fulfill the request to build the table and answer the specific questions about the study based on the provided text.

    To provide the requested information, a document containing the technical specifications, performance claims, and the study report (or summary of the study results) would be necessary.

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