The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Digital X-ray Imaging System, Model Pax-uni3d.
Device ID | K090467 |
510k Number | K090467 |
Device Name: | DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D |
Classification | X-ray, Tomography, Computed, Dental |
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 | OAS |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-23 |
Decision Date | 2010-01-08 |
Summary: | summary |