The following data is part of a premarket notification filed by Viztek, Inc. with the FDA for Viztek Dr, Models: Dr1000, Dr3000, Dr4000.
| Device ID | K082604 |
| 510k Number | K082604 |
| Device Name: | VIZTEK DR, MODELS: DR1000, DR3000, DR4000 |
| 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 | 2008-09-08 |
| Decision Date | 2008-11-21 |
| Summary: | summary |