K201101 is an FDA 510(k) clearance for the 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder 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 June 2, 2020, 39 days after receiving the submission on April 24, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K201101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2020 |
| Decision Date | June 02, 2020 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| 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 |