The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Computed Tomography X-ray System.
| Device ID | K102196 |
| 510k Number | K102196 |
| Device Name: | COMPUTED TOMOGRAPHY X-RAY SYSTEM |
| Classification | X-ray, Tomography, Computed, Dental |
| 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 | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2011-03-25 |
| Summary: | summary |