K113474 is an FDA 510(k) clearance for the 1.5T GEM FLEX COIL. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Neocoil, LLC (Pewaukee, US). The FDA issued a Cleared decision on March 16, 2012, 115 days after receiving the submission on November 22, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K113474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2011 |
| Decision Date | March 16, 2012 |
| Days to Decision | 115 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MOS - Coil, Magnetic Resonance, Specialty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |