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510(k) Data Aggregation

    K Number
    K011991
    Device Name
    MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
    Manufacturer
    MEDRAD, INC.
    Date Cleared
    2001-08-21

    (56 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spectris MR Injection System with Communicator ™ is a syringe-based fluid delivery System intended to be used for the specific purpose of injecting intravenous contrast media during Magnetic Resonance Imaging applications. It is intended to be used for intravenous access for diagnostic studies in Magnetic Resonance Imaging. The Communicator connection provides an imaging system interface. Properly trained healthcare professionals are intended to operate this device.

    Device Description

    Medrad Spectris MR Injector with Communicator™ Option is a syringe-based fluid delivery system.

    AI/ML Overview

    The document provided is an FDA clearance letter and an Indications for Use statement for the Medrad Spectris MR Injector with Communicator™ option. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to its performance in a clinical or analytical setting.

    Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, and not on detailed performance study results against specific acceptance criteria.

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