3.0T AIR 32CH HNA

The 3.0T AIR 32CH HNA is a receive-only radiofrequency coil for GE HealthCare 3.0T MRI systems designed for high-resolution magnetic resonance imaging of the head and brain. When used with a Posterior Array, it also enables imaging of the neck, cervical spine, neurovascular structures, upper thoracic spine, and brachial plexus. The device is intended for diagnostic use in hospital or clinical settings operated by a Registered MRI Technologist.

The most significant technological difference between the 3.0T AIR 32CH HNA and the predicate 48-channel Head Coil is the inclusion of an additional AIR Neck-Chest Unit. Both devices are receive-only RF coils with comparable design and function, though the new device adds expandable coverage through the neck-chest component.

Image Signal-to-Noise Ratio (SNR) per NEMA MS-9; Image Uniformity per NEMA MS-9; Surface heating per NEMA MS-14; EMC testing per IEC 60601-1-2; General electrical and mechanical safety per AAMI/ANSI ES 60601-1 and IEC 60601-2-33; Biocompatibility per ISO 10993 series; and clinical image quality assessment by a board-certified radiologist.

Both the new device and predicate are classified as MRI coils for diagnostic use with functional indications for use statements targeting the same patient population and clinical setting. The technological differences do not raise different safety and effectiveness questions, as both must provide adequate image quality for diagnostic purposes. Non-clinical and clinical testing demonstrate comparable or superior performance, satisfying FDA guidance criteria for receive-only coils.