The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Digital Flat Panel X-ray Detector.
| Device ID | K101590 |
| 510k Number | K101590 |
| Device Name: | DIGITAL FLAT PANEL X-RAY DETECTOR |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | VATECH CO., LTD. 333 MEADOWLANDS PARKWAY #303 Secaucus, NJ 07094 |
| Contact | Dave Kim |
| Correspondent | Dave Kim VATECH CO., LTD. 333 MEADOWLANDS PARKWAY #303 Secaucus, NJ 07094 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2010-11-29 |
| Summary: | summary |