The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Dental Computed Tomography X-ray System.
Device ID | K102124 |
510k Number | K102124 |
Device Name: | DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM |
Classification | System, X-ray, Extraoral Source, Digital |
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 | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-29 |
Decision Date | 2010-10-22 |
Summary: | summary |