The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for 1.5t 16ch Breast Coil.
| Device ID | K182958 |
| 510k Number | K182958 |
| Device Name: | 1.5T 16ch Breast Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NeoCoil, LLC N27 W23910 A Paul Rd. Pewaukee, WI 53072 |
| Contact | Katie Gonzalez |
| Correspondent | Katie Gonzalez NeoCoil, LLC N27 W23910 A Paul Rd. 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 | 2018-10-24 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003893 | K182958 | 000 |