K111304 is an FDA 510(k) clearance for the OPTIMA XR120. This device is classified as a Device, Spot-film (Class II - Special Controls, product code IXL).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on July 19, 2011, 71 days after receiving the submission on May 9, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1670.
| 510(k) Number | K111304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2011 |
| Decision Date | July 19, 2011 |
| Days to Decision | 71 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXL — Device, Spot-film |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1670 |