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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIDELITY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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