The following data is part of a premarket notification filed by Ray Co.,ltd with the FDA for Rct700.
| Device ID | K182614 |
| 510k Number | K182614 |
| Device Name: | RCT700 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-21 |
| Decision Date | 2018-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003001002 | K182614 | 000 |
| 08800003001279 | K182614 | 000 |
| 08800003001262 | K182614 | 000 |
| 08800003001248 | K182614 | 000 |
| 08800003001231 | K182614 | 000 |
| 08800003001224 | K182614 | 000 |
| 08800003001217 | K182614 | 000 |
| 08800003001194 | K182614 | 000 |
| 08800003001187 | K182614 | 000 |