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510(k) Data Aggregation

    K Number
    K022720
    Device Name
    CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2002-09-06

    (22 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    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 spine that can be interpreted by a trained physician.

    Device Description

    Model CTL-63-8 Cervical/Thoracic/Lumbar Array Coil

    AI/ML Overview

    I am unable to provide a description of the acceptance criteria and study as the provided text is a 510(k) clearance letter and does not contain the specific details about device performance, study design, or ground truth establishment. This document only confirms the FDA's regulatory clearance for the device Model CTL-63-8 Cervical Thoracic/Lumbar Array Coil based on substantial equivalence to a predicate device.

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