The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for 16ch Breast Coil / 16ch Breast Coils, 1.5t 16ch Breast Coil, 3.0t 16ch Breast Coil, 1.5t 16ch Breast Coil, 3t 16ch Breast Coil.
| Device ID | K222407 |
| 510k Number | K222407 |
| Device Name: | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-09 |
| Decision Date | 2022-10-14 |