The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Pax-duo3d Plus, Pct-5000.
| Device ID | K121236 |
| 510k Number | K121236 |
| Device Name: | PAX-DUO3D PLUS, PCT-5000 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | VATECH CO., LTD. 12946 KIMBERLEY LN Houston, TX 77079 |
| Contact | Dave Kim |
| Correspondent | Dave Kim VATECH CO., LTD. 12946 KIMBERLEY LN Houston, TX 77079 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-24 |
| Decision Date | 2012-05-24 |
| Summary: | summary |