The following data is part of a premarket notification filed by Viztek, Inc. with the FDA for Vizion Dr.
| Device ID | K102123 |
| 510k Number | K102123 |
| Device Name: | VIZION DR |
| Classification | System, X-ray, Stationary |
| Applicant | VIZTEK, INC. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. VIZTEK, INC. 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2011-01-24 |
| Summary: | summary |