The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for 32ch Air Open Coil Suite: 1.5t Air Open Head Neck Posterior 9ch / 3.0t Air Open Head Neck Posterior 9ch, 1.5t Air Open Neck Chest Anterior 7ch / 3.0t Air Open Neck Chest Anterior 7ch, 1.5t Air Open Head Anterior 16ch / 3.0t Air Open Head Anterior 16c.
| Device ID | K213687 |
| 510k Number | K213687 |
| Device Name: | 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16c |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NeoCoil, LLC N27 W23910A Paul Road Pewaukee, WI 53072 |
| Contact | Katie Gonzalez |
| Correspondent | Katie Gonzalez NeoCoil, LLC N27 W23910A Paul Road Pewaukee, WI 53072 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-23 |
| Decision Date | 2022-03-11 |