The 32Ch AIR Open Coil Suite, 3.0T (NeoCoil Ref#: NC139020; GEHC Ref#: M7024RT) is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise…
The 32Ch AIR Open Coil Suite, 3.0T (NeoCoil Ref#: NC139020; GEHC Ref#: M7024RT) 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 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).
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (2), Tianjin (2).
Record
Regulatory record for 32ch AIR Open Coil Suite, 3.0T | Listed by | Neocoil, LLC, United States |
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K213687 |
| Record published | 2023-01-27 |
| Record revised | 2025-07-16 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.