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510(k) Data Aggregation

    K Number
    K011611
    Device Name
    CARDIOCAM MODEL 9CSY0799
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Date Cleared
    2001-06-08

    (14 days)

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

    CARDIOCAM MODEL 9CSY0799

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

    The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, intages are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, Tl-201, Co-57.

    Device Description

    The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), or the results of any comparative effectiveness or standalone studies. The document is an FDA 510(k) clearance letter for the Cardiocam Model 9CSY0799, confirming its substantial equivalence to a predicate device and specifying its indications for use. It does not include the technical study details that would be required to answer your request.

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