The following data is part of a premarket notification filed by Viztek Llc with the FDA for Vizion Dr + Wireless.
| Device ID | K152279 |
| 510k Number | K152279 |
| Device Name: | ViZion DR + Wireless |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | VIZTEK LLC 2217 US HWY 70 EAST Garner, NC 27529 |
| Contact | Bruce Ashby |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 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 | 2015-08-12 |
| Decision Date | 2015-09-10 |
| Summary: | summary |