The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Digital X-ray Imaging System, Model Drc-1000.
| Device ID | K092830 |
| 510k Number | K092830 |
| Device Name: | DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 |
| Classification | System, X-ray, Stationary |
| Applicant | VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E. SUITE 115 Houston, TX 77060 |
| Contact | Vincent Lee |
| Correspondent | Vincent Lee VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E. SUITE 115 Houston, TX 77060 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-14 |
| Decision Date | 2010-07-21 |
| Summary: | summary |