Xoran Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 7
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1210-2015 | Class II | Xoran MiniCAT X-ray imaging device | September 8, 2014 |
| Z-0038-2014 | Class II | Xoran Minicat00202 | July 27, 2010 |
| Z-0036-2014 | Class II | Xoran Mini CT Scanner | July 27, 2010 |
| Z-0037-2014 | Class II | Xoran MiniCAT CT Scanner | July 27, 2010 |
| Z-0040-2014 | Class II | Xoran MiniCAT00202 | July 27, 2010 |
| Z-0039-2014 | Class II | Xoran Minicat00158 | July 27, 2010 |
| Z-0041-2014 | Class II | Xoran MiniCAT CT Scanner ID ENT00001 | December 14, 2009 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K221230 | TRON | July 28, 2022 |
| K210257 | Xoran Workstation, Model 10050 | May 20, 2021 |
| K201825 | MiniCAT 2D | November 20, 2020 |
| K113421 | MINICAT | July 11, 2012 |
| K073306 | XORANCONNECT | January 7, 2008 |
| K061834 | XCAT; XCAT FOR NEURO | August 7, 2006 |
| K032243 | MINICAT DENTOCAT | October 2, 2003 |