The following data is part of a premarket notification filed by Ray Co., Ltd with the FDA for Rayscan A-expert.
| Device ID | K142058 |
| 510k Number | K142058 |
| Device Name: | RAYSCAN A-EXPERT |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | RAY CO., LTD 4747 HOEN AVE. Santa Rosa, CA 95405 |
| Contact | Andew Paeng |
| Correspondent | Andew Paeng RAY CO., LTD 4747 HOEN AVE. Santa Rosa, CA 95405 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-29 |
| Decision Date | 2015-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003000050 | K142058 | 000 |
| 08800003000043 | K142058 | 000 |
| 08800003000036 | K142058 | 000 |
| 08800003000029 | K142058 | 000 |