K122646 is an FDA 510(k) clearance for the DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T. 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 November 2, 2012, 64 days after receiving the submission on August 30, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K122646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2012 |
| Decision Date | November 02, 2012 |
| Days to Decision | 64 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 |