The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for System, X-ray, Extra Oral Source, Digital, Pax-i Plus, Pax-i Insight.
| Device ID | K170731 |
| 510k Number | K170731 |
| Device Name: | System, X-Ray, Extra Oral Source, Digital, PaX-i Plus, PaX-i Insight |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si, KR 445-170 |
| Contact | Daniel Kim |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-10 |
| Decision Date | 2017-04-04 |
| Summary: | summary |