The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Imaging Plate Scanner, I-scan.
| Device ID | K212080 |
| 510k Number | K212080 |
| Device Name: | Imaging Plate Scanner, I-Scan |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-02 |
| Decision Date | 2021-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944843605647 | K212080 | 000 |
| 06944843605630 | K212080 | 000 |
| 00837699000109 | K212080 | 000 |
| 00990010301290 | K212080 | 000 |