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510(k) Data Aggregation

    K Number
    K040348
    Device Name
    MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2004-03-09

    (26 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL

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

    To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.

    Device Description

    Model HNC-127-INT Neurovascular Array Coil

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device, specifically an MRI coil. It does not contain the requested information regarding acceptance criteria, study data, or ground truth establishment for an AI/ML powered device.

    The letter confirms that the Model HNC-127-INT Neurovascular Array Coil is substantially equivalent to legally marketed predicate devices and can be used to produce diagnostic images of the head and neck. It outlines regulatory requirements for the device but does not describe any performance studies or acceptance criteria that would be relevant to an AI/ML powered device.

    Therefore, I cannot provide the requested information from the provided text.

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