The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Ai Ray Dental X-ray Device.
| Device ID | K222569 |
| 510k Number | K222569 |
| Device Name: | Ai Ray Dental X-Ray Device |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin City, CN 541004 |
| Contact | Xunxian Wu |
| Correspondent | Charles Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-24 |
| Decision Date | 2022-11-23 |