NEOCOIL, LLC

Address:N27 W23910A PAUL RD.,Pewaukee,WI,53072,US

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Device Description : The NeoCoil Wireless Audio System is intended to provide entertainment and facil The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Device Description : The NeoCoil Wireless Audio System is intended to provide entertainment and facil The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Device Description : The NeoCoil Wireless Audio System is intended to provide entertainment and facil The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Device Description : The NeoCoil Wireless Audio System is intended to provide entertainment and facil The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Device Description : The NeoCoil Wireless Audio System is intended to provide entertainment and facil The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Device Description : The NeoCoil Wireless Audio System is intended to provide entertainment and facil The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Device Description : The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

Device Description : The NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures The NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 1.5T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The 1.5T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

Device Description : The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optim The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform coverage of the shoulder anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings.The received signals are amplified before being transferred to the MRI scanner through the coil’s system cable. The amplified signals are processed into tomographic images of the shoulder anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy.During a shoulder MRI exam, the patient lays in the supine position on the MRI scanner table. The rigid Posterior Array is positioned beneath the patient’s affected shoulder. The flexible Anterior Array is positioned on top of the patient’s affected shoulder. The 16ch Shoulder Posterior Housing Pad and 16ch Shoulder Pad provided with the coil promote patient comfort and facilitate patient positioning. Table Straps provided with the MRI scanner may be used to minimize unintended patient movement during the exam.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

Device Description : The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optim The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniformcoverage of the shoulder anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The coil receivesmagnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magneticfield applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRIscanner through the coil’s system cable. The amplified signals are processed into tomographic images of the shoulder anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy. During a shoulder MRI exam, the patient lays in the supine position on the MRI scanner table. The rigid Posterior Array is positioned beneath the patient’s affected shoulder. The flexible Anterior Array is positioned on top of the patient’s affected shoulder. The 16ch Shoulder Posterior Housing Pad and 16ch Shoulder Pad provided with the coil promote patient comfort and facilitate patient positioning. Table Straps provided with the MRI scanner may be used to minimize unintended patient movement during the exam.

Device Class : 2

Duns Number: 781155176

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1