K093284 is an FDA 510(k) clearance for the 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL. 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 February 1, 2010, 104 days after receiving the submission on October 20, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K093284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2009 |
| Decision Date | February 01, 2010 |
| Days to Decision | 104 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 |