The following data is part of a premarket notification filed by Viztek, Inc. with the FDA for Viztek Wl.
| Device ID | K091752 |
| 510k Number | K091752 |
| Device Name: | VIZTEK WL |
| Classification | System, X-ray, Stationary |
| Applicant | VIZTEK, INC. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm VIZTEK, INC. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-11-12 |
| Summary: | summary |