The following data is part of a premarket notification filed by Ray Co., Ltd with the FDA for Rayscan A-expert.
| Device ID | K131693 |
| 510k Number | K131693 |
| Device Name: | RAYSCAN A-EXPERT |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | RAY CO., LTD 4747 HOEN AVE. Santa Rosa, CA 95405 |
| Contact | Andrew Paeng |
| Correspondent | Andrew Paeng RAY CO., LTD 4747 HOEN AVE. Santa Rosa, CA 95405 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-10 |
| Decision Date | 2013-11-01 |
| Summary: | summary |