The following data is part of a premarket notification filed by Ray Co., Ltd with the FDA for Rct700.
| Device ID | K213226 |
| 510k Number | K213226 |
| Device Name: | RCT700 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | RAY Co., Ltd 332-7, Samsung 1-ro Hwaseong-si, KR 18380 |
| Contact | Youna Im |
| Correspondent | Youna Im 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 | 2021-09-29 |
| Decision Date | 2021-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003001347 | K213226 | 000 |
| 08800003001361 | K213226 | 000 |
| 08800003001378 | K213226 | 000 |
| 08800003001385 | K213226 | 000 |
| 08800003001392 | K213226 | 000 |
| 08800003001408 | K213226 | 000 |
| 08800003001415 | K213226 | 000 |
| 08800003001422 | K213226 | 000 |
| 08800003001439 | K213226 | 000 |
| 08800003001446 | K213226 | 000 |
| 08800003001316 | K213226 | 000 |
| 08800003001323 | K213226 | 000 |
| 08800003001330 | K213226 | 000 |
| 08800003001354 | K213226 | 000 |