K162001 is an FDA 510(k) clearance for the 1.5T and 3.0T 16 CH GE Shoulder Coils. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Invivo Corporation (Florida, US). The FDA issued a Cleared decision on August 31, 2016, 42 days after receiving the submission on July 20, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K162001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2016 |
| Decision Date | August 31, 2016 |
| Days to Decision | 42 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 |