Imaging Sciences International, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2463-2012 | Class II | DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiologic | July 30, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | November 10, 2016 |
| K133620 | CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM | May 14, 2014 |
| K140445 | DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC | April 23, 2014 |