K103476 is an FDA 510(k) clearance for the BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on June 16, 2011, 204 days after receiving the submission on November 24, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K103476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2010 |
| Decision Date | June 16, 2011 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL — System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |