K123345 is an FDA 510(k) clearance for the DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Rayence Co., Ltd. (Houston, US). The FDA issued a Cleared decision on March 12, 2013, 132 days after receiving the submission on October 31, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K123345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2012 |
| Decision Date | March 12, 2013 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB — Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |