| Primary Device ID | 00856181003961 |
| NIH Device Record Key | 415cb968-7adc-46c1-8ad8-d32b5f43e6b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 16ch Shoulder Coil, Replacement Pad Kit (FRU) |
| Version Model Number | 96 |
| Catalog Number | NC143005 |
| Company DUNS | 781155176 |
| Company Name | NEOCOIL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
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| 00856181003916 - 1.5T 16ch Shoulder Coil (Device) | 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform
cover |
| 00856181003947 - 3.0T 16ch Shoulder Coil (FRU) | 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover |
| 00856181003954 - 1.5T 16ch Shoulder Coil (FRU) | 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover |
| 00856181003961 - 16ch Shoulder Coil, Replacement Pad Kit (FRU) | 2021-01-12The 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. |
| 00856181003961 - 16ch Shoulder Coil, Replacement Pad Kit (FRU) | 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover |