The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Dental Computed Tomography X-ray System, Pht-30lfo, Pax-i3d Smart.
| Device ID | K152106 |
| 510k Number | K152106 |
| Device Name: | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | VATECH CO., LTD 13, SAMSUNG 1-RO 2-GIL Hwaseong-si, KR 445-170 |
| Contact | Daniel Kim |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-29 |
| Decision Date | 2015-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800016400625 | K152106 | 000 |
| 08800016400618 | K152106 | 000 |