| Primary Device ID | 00850028932506 |
| NIH Device Record Key | 6714a462-f503-4154-b85e-80b555e2ac9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 32ch AIR Open Coil Suite, 1.5T |
| Version Model Number | 50 |
| Catalog Number | NC139021 |
| 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 | false |
| 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 |
| 00850028932490 - 32ch AIR Open Coil Suite, 3.0T | 2025-05-26 The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to |
| 00850028932506 - 32ch AIR Open Coil Suite, 1.5T | 2025-05-26The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise ratio (SNR) and uniform coverage of the Head, Neck and Brachial Plexus anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T and 3.0T field strengths:
• AIR Open Head Neck Posterior 9ch
• AIR Open Neck Chest Anterior 7ch
• AIR Open Head Anterior 16ch
The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy 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 by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MRI Overlay for compatible MR table(s) and associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner). |
| 00850028932506 - 32ch AIR Open Coil Suite, 1.5T | 2025-05-26 The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to |
| 00850028932452 - 3T 16ch Breast Coil | 2023-03-31 |
| 00850028932469 - 1.5T 16ch Breast Coil | 2023-03-31 |
| 00850028932513 - Biopsy Grid Assembly, Pack, Breast Coil | 2023-03-31 |
| 00850028932520 - Drape Pack, Biopsy, Breast Coil | 2023-03-31 |
| 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 |