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510(k) Data Aggregation

    K Number
    K024354
    Device Name
    PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2003-01-09

    (10 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 pediatric head and spine, that can be interpreted by a trained physician.

    Device Description

    Model PHSL-63-SYM and PHS-63-SYM Pediatric Head and Spine Array Coils

    AI/ML Overview

    The provided text does not contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device's performance. The document is a 510(k) clearance letter from the FDA for pediatric head and spine array coils, affirming their substantial equivalence to predicate devices and detailing regulatory information. It does not include a performance study.

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