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510(k) Data Aggregation

    K Number
    K983088
    Device Name
    INSTACINE D-2000
    Manufacturer
    FIDELITY MEDICAL, INC.
    Date Cleared
    1998-09-22

    (25 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InstaCine D-2000 system enables acquisition, display, electronic processing, storage and review of radiographic images generated during certain medical procedures, particularly cardiac anglographic The product is intended and radiographic/fluroscopic examinations. primarily for on-line or remore viewing of cardiac catheterization angiography studies communicated by network, or trquaporced by CD-R interchange media which have been produced in accordance with the ACC/NEMA DICOMO standard.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter and an "Indications For Use" statement. It establishes the device's substantial equivalence and outlines its intended use, but it does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based solely on the input provided. The document primarily focuses on regulatory approval and the device's function rather than performance metrics or detailed study results.

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