The following data is part of a premarket notification filed by Iray Technology Taicang Ltd. with the FDA for Plutox Digital Intraoral X-ray Imaging System.
| Device ID | K210312 |
| 510k Number | K210312 |
| Device Name: | PlutoX 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 Ticang, CN 215434 |
| Contact | Wei Pan |
| Correspondent | Wei Pan iRay Technology Taicang Ltd. No.33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Ticang, 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 | 2021-02-03 |
| Decision Date | 2021-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08055060430450 | K210312 | 000 |
| 08055060430443 | K210312 | 000 |
| 08055060430436 | K210312 | 000 |
| 08055060430429 | K210312 | 000 |