The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Pch-2500 Digital Extraoral Source X-ray System, Pax-i Digital Extraoral Source X-ray System.
| Device ID | K130585 |
| 510k Number | K130585 |
| Device Name: | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-05 |
| Decision Date | 2013-07-15 |
| Summary: | summary |