VIX WIN PRO
FDA 510(k) clearance K060178 · decided 2006-03-10
Clearance details
- K-number
- K060178
- Device name
- VIX WIN PRO
- Applicant
- Gendex Dental Systems
- Decision
- Substantially Equivalent
- Date received
- 2006-01-23
- Decision date
- 2006-03-10
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, recall (Z-1548-2009) | Gendex Dental Systems | 2009-07-17 |