The following data is part of a premarket notification filed by Mtech Group with the FDA for Pht-6500; Pht-60cfo; Pax-i3d.
| Device ID | K122606 |
| 510k Number | K122606 |
| Device Name: | PHT-6500; PHT-60CFO; PAX-I3D |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | MTECH GROUP 12946 KIMBERLEY LN Houston, TX 77079 |
| Contact | Dave Kim |
| Correspondent | Dave Kim MTECH GROUP 12946 KIMBERLEY LN Houston, TX 77079 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-27 |
| Decision Date | 2012-11-20 |
| Summary: | summary |