The following data is part of a premarket notification filed by Gendex Dental Systems with the FDA for Vix Win Pro.
| Device ID | K060178 |
| 510k Number | K060178 |
| Device Name: | VIX WIN PRO |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | GENDEX DENTAL SYSTEMS PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm GENDEX DENTAL SYSTEMS PO BOX 7007 Deerfield, IL 60015 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-23 |
| Decision Date | 2006-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101037680 | K060178 | 000 |