The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Pax-i3d Green Premium (model: Pct-90lh).
| Device ID | K160882 |
| 510k Number | K160882 |
| Device Name: | PaX-i3D Green Premium (Model: PCT-90LH) |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | VATECH CO., LTD 13, SAMSUNG 1-RO 2-GIL Hwaseong-si, KR 18449 |
| Contact | Daniel Kim |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-31 |
| Decision Date | 2016-10-28 |
| Summary: | summary |