The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Digital X-ray Imaging System (pax-primo) Model Pax-primo.
| Device ID | K100317 |
| 510k Number | K100317 |
| Device Name: | DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E. # 115 Houston, TX 77060 |
| Contact | Dave Kim |
| Correspondent | Dave Kim VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E. # 115 Houston, TX 77060 |
| Product Code | MUH |
| Subsequent Product Code | EHD |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2010-03-24 |