Impac Medical Systems Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1944-2012 | Class II | MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled ele | June 8, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K151233 | Monaco | July 7, 2015 |
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | September 5, 2014 |
| K132971 | MONACO | November 20, 2013 |
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | December 12, 2012 |
| K120067 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | February 28, 2012 |
| K043412 | MODIFICATION TO: VIEWSTATION | December 20, 2004 |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | November 7, 2001 |
| K011694 | VIEWSTATION | August 29, 2001 |
| K991133 | MLC FIT | March 27, 2000 |
| K981313 | SEQUENCER | July 9, 1998 |
| K962335 | MLC FIT | February 6, 1997 |
| K942346 | IMAGERT | May 15, 1995 |
| K913612 | SEQUENCER | December 19, 1991 |