The following data is part of a premarket notification filed by Ray Co., Ltd with the FDA for Rayscan A-expert3d.
| Device ID | K190812 |
| 510k Number | K190812 |
| Device Name: | RAYSCAN A-Expert3D |
| 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 | 2019-03-29 |
| Decision Date | 2019-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003000197 | K190812 | 000 |
| 08800003000180 | K190812 | 000 |
| 08800003000173 | K190812 | 000 |
| 08800003000166 | K190812 | 000 |
| 08800003000159 | K190812 | 000 |