Chicago X-Ray Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1179-2013 | Class II | Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for d | July 3, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K972968 | ROTOGRAPH PLUS | October 8, 1997 |
| K954565 | EXPLOR-X (AZTEH) HF | October 27, 1995 |
| K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | April 6, 1995 |
| K931300 | FLASH DENT | March 21, 1994 |