K122897 is an FDA 510(k) clearance for the SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646. 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 December 21, 2012, 91 days after receiving the submission on September 21, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K122897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2012 |
| Decision Date | December 21, 2012 |
| Days to Decision | 91 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 |