K131693 is an FDA 510(k) clearance for the RAYSCAN A-EXPERT. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Ray Co., Ltd. (Santa Rosa, US). The FDA issued a Cleared decision on November 1, 2013, 144 days after receiving the submission on June 10, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K131693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2013 |
| Decision Date | November 01, 2013 |
| Days to Decision | 144 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUH — System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |