The following data is part of a premarket notification filed by Viztek Llc with the FDA for Vizion Dr + Wireless.
| Device ID | K160810 |
| 510k Number | K160810 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-24 |
| Decision Date | 2016-05-20 |
| Summary: | summary |