The following data is part of a premarket notification filed by Viztek Llc with the FDA for Vizion Ultra.
| Device ID | K133139 |
| 510k Number | K133139 |
| Device Name: | VIZION ULTRA |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | VIZTEK LLC 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. VIZTEK LLC 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-04-03 |
| Summary: | summary |