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510(k) Data Aggregation

    K Number
    K031536
    Device Name
    BRAIN COIL, MODEL 9900GE-64
    Manufacturer
    CLINICAL MR SOLUTIONS, LLC
    Date Cleared
    2003-07-18

    (63 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head. This device is used in conjunction with a General Electric 1.5 Tesla MRI Scanner and for Spectroscopy will need the addition of the PROBE (Proton Brain Exam) software option.

    Device Description

    Brain Coil, Model # 9900GE-64

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for a medical device. It does NOT contain the acceptance criteria, reported device performance, or study details requested.

    The document is a letter from the FDA to Clinical MR Solutions, LLC, confirming the substantial equivalence of their "Brain Coil, Model # 9900GE-64" to legally marketed predicate devices. It states that the device is a Magnetic Resonance Diagnostic Device (21 CFR 892.1000, Regulatory Class II).

    The "Indications for Use" section (Attachment 3) describes what the device is intended for:

    • 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head.
    • It is used in conjunction with a General Electric 1.5 Tesla MRI Scanner.
    • For Spectroscopy, it requires the addition of the PROBE (Proton Brain Exam) software option.

    Therefore, I cannot provide the requested information from this document. This document focuses on regulatory approval based on substantial equivalence, not on specific performance studies or acceptance criteria for a new AI/software device. It predates the widespread use of AI in medical devices by many years (2003).

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