The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for Neocoil 1.5t 16 Channel Cardiac-abdominal-pelvic Array Coil.
| Device ID | K073181 |
| 510k Number | K073181 |
| Device Name: | NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NEOCOIL, LLC N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Contact | Brian Brown |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2007-11-21 |
| Summary: | summary |