The following data is part of a premarket notification filed by Iray Technology Taicang Ltd. with the FDA for Dental Sensors Nanopix1, Nanopix2.
| Device ID | K220422 |
| 510k Number | K220422 |
| Device Name: | Dental Sensors NanoPix1, NanoPix2 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972597784974 | K220422 | 000 |
| 06972597784837 | K220422 | 000 |