The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Vex-s 100w Intraoral X-ray System.
| Device ID | K123493 |
| 510k Number | K123493 |
| Device Name: | VEX-S 100W INTRAORAL X-RAY SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| 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 | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-09 |
| Decision Date | 2012-12-13 |
| Summary: | summary |