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510(k) Data Aggregation

    K Number
    K253738

    Validate with FDA (Live)

    Date Cleared
    2026-01-23

    (60 days)

    Product Code
    Regulation Number
    892.1000
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 3.0T AIR™ 32CH HNA is a receive-only RF Coil designed for use with GE HealthCare 3.0T MRI systems. The coil is indicated for high-resolution magnetic resonance imaging (MRI) of the head and brain. When used with a Posterior Array in the MRI System patient table it also includes neck, cervical spine, neurovascular structures, upper thoracic spine, and brachial plexus imaging. The nucleus detected is hydrogen.

    Device Description

    The 3.0T AIR 32CH HNA is a receive-only radio frequency coil engineered to deliver optimal signal-to-noise ratio, uniform anatomical coverage, and high acceleration capabilities, including multiband imaging. It is intended for high-resolution magnetic resonance imaging (MRI) of the head and brain. When used in conjunction with the Posterior Array in the MRI system's patient table, it also supports imaging of the neck, cervical spine, neurovascular structures, upper thoracic spine, and brachial plexus. The nucleus detected is hydrogen. This coil is compatible with GE HealthCare 3.0T MRI systems.

    The 3.0T AIR 32CH HNA is designed to be used by a Registered MRI Technologist in a hospital or clinical setting. The Registered MRI Technologist will operate the scanner from the control room. If the patient is claustrophobic another MRI Technologist or clinical staff member may stay in the magnet room with the patient.

    AI/ML Overview

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