The following data is part of a premarket notification filed by Iray Technology Taicang Ltd. with the FDA for Digital Intraoral X-ray Imaging System.
| Device ID | K212279 |
| 510k Number | K212279 |
| Device Name: | Digital Intraoral X-ray Imaging System |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | iRay Technology Taicang Ltd. No. 33 Xinggang Rd. Taicang Port Economic & Technological Development Zone Taicang, CN 215434 |
| Contact | Guo Wu |
| Correspondent | Wei Pan iRay Technology Taicang Ltd. No. 33 Xinggang Rd. Taicang Port Economic & Technological Development Zone Taicang, CN 215434 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2021-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944843605432 | K212279 | 000 |
| 00990010301276 | K212279 | 000 |
| 00990010302464 | K212279 | 000 |
| 00990010302471 | K212279 | 000 |
| 00990010302402 | K212279 | 000 |
| 00990010302419 | K212279 | 000 |
| 00990010302426 | K212279 | 000 |
| 00990010302433 | K212279 | 000 |
| 00990010302440 | K212279 | 000 |
| 00990010302457 | K212279 | 000 |
| 00837699000079 | K212279 | 000 |
| 00837699000086 | K212279 | 000 |
| 06944843611099 | K212279 | 000 |
| 06944843611242 | K212279 | 000 |
| 06944843605302 | K212279 | 000 |
| 06944843605319 | K212279 | 000 |
| 06944843605425 | K212279 | 000 |
| 00990010301269 | K212279 | 000 |