The following data is part of a premarket notification filed by Shenzhen Xpectvision Technology Co.,ltd. with the FDA for Digital Intraoral X-ray Sensor.
| Device ID | K220277 |
| 510k Number | K220277 |
| Device Name: | Digital Intraoral X-ray Sensor |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Shenzhen Xpectvision Technology Co.,Ltd. B507,Block A And B,Nanshan Medical Device Industrial Park, Nanhai Avenue 1019,Nanshan District Shenzhen, CN 518067 |
| Contact | Mengsi Peng |
| Correspondent | Mengsi Peng Shenzhen Xpectvision Technology Co.,Ltd. B507,Block A And B,Nanshan Medical Device Industrial Park, Nanhai Avenue 1019,Nanshan District Shenzhen, CN 518067 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972259248011 | K220277 | 000 |
| 06972259248004 | K220277 | 000 |
| 00872320006464 | K220277 | 000 |
| 00872320006457 | K220277 | 000 |