The following data is part of a premarket notification filed by Ray Co., Ltd with the FDA for Rct800.
| Device ID | K192737 |
| 510k Number | K192737 |
| Device Name: | RCT800 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | RAY CO., Ltd 332-7, Samsung 1-ro Hwaseong-si, KR 18380 |
| Contact | Changhwan Lee |
| Correspondent | Changhwan Lee RAY CO., Ltd 332-7, Samsung 1-ro Hwaseong-si, KR 18380 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2019-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003004201 | K192737 | 000 |
| 08800003004195 | K192737 | 000 |
| 08800003004188 | K192737 | 000 |
| 08800003004171 | K192737 | 000 |