The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for 1.5t Gem Flex Coil.
| Device ID | K113474 |
| 510k Number | K113474 |
| Device Name: | 1.5T GEM FLEX COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NEOCOIL, LLC N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Contact | Steven Nichols |
| Correspondent | Steven Nichols NEOCOIL, LLC N27 W23910A PAUL RD. Pewaukee, WI 53072 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-22 |
| Decision Date | 2012-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003657 | K113474 | 000 |
| 00856181003497 | K113474 | 000 |
| 00856181003480 | K113474 | 000 |
| 00856181003473 | K113474 | 000 |
| 00856181003466 | K113474 | 000 |
| 00856181003459 | K113474 | 000 |
| 00856181003268 | K113474 | 000 |
| 00856181003237 | K113474 | 000 |
| 00856181003107 | K113474 | 000 |
| 00856181003091 | K113474 | 000 |
| 00856181003084 | K113474 | 000 |
| 00856181003077 | K113474 | 000 |
| 00856181003503 | K113474 | 000 |
| 00856181003510 | K113474 | 000 |
| 00856181003527 | K113474 | 000 |
| 00856181003640 | K113474 | 000 |
| 00856181003633 | K113474 | 000 |
| 00856181003626 | K113474 | 000 |
| 00856181003619 | K113474 | 000 |
| 00856181003602 | K113474 | 000 |
| 00856181003596 | K113474 | 000 |
| 00856181003589 | K113474 | 000 |
| 00856181003572 | K113474 | 000 |
| 00856181003565 | K113474 | 000 |
| 00856181003541 | K113474 | 000 |
| 00856181003534 | K113474 | 000 |
| 00856181003060 | K113474 | 000 |