The following data is part of a premarket notification filed by Ray Co., Ltd with the FDA for Rioscan (rps500).
| Device ID | K160788 |
| 510k Number | K160788 |
| Device Name: | RIOScan (RPS500) |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | RAY CO., Ltd 332-7, Samsung 1-ro Hwaseong-si, KR 445-330 |
| Contact | Changhwan Lee |
| Correspondent | Changhwan Lee RAY CO., Ltd 332-7, Samsung 1-ro Hwaseong-si, KR 445-330 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-22 |
| Decision Date | 2016-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003003372 | K160788 | 000 |
| 08800003003365 | K160788 | 000 |
| 08800003003358 | K160788 | 000 |
| 08800003003341 | K160788 | 000 |
| 08800003003334 | K160788 | 000 |
| 08800003003327 | K160788 | 000 |
| 08800003003310 | K160788 | 000 |
| 08800003003020 | K160788 | 000 |
| 08800003003013 | K160788 | 000 |