IMRIS Inc
FDA Regulatory Profile
IMRIS Inc appears in FDA public data with 1 recall, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0144-2015, Class II) was initiated on October 1, 2014. Its most recent 510(k) clearance was granted on October 30, 2015.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0144-2015 | Class II | IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations o | October 1, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K143420 | SYMBIS Surgical System | October 30, 2015 |
| K141950 | HFD100 ROCKER ARM ACCESSORY | September 4, 2014 |
| K133692 | IMRI 1.5T AND IMRI 3T S | February 10, 2014 |
| K130224 | ICT | July 18, 2013 |
| K123091 | VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T | December 27, 2012 |
| K121997 | IMRIS ONCOLOGY PACKAGE | August 10, 2012 |
| K113748 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | March 23, 2012 |
| K103493 | HEAD FIATION DEVICE (HFD 100) | March 11, 2011 |
| K103506 | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) | February 2, 2011 |
| K101813 | IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO | October 5, 2010 |
| K091166 | IMRX | September 2, 2009 |
| K083137 | NEURO III-SV | December 16, 2008 |
| K071099 | NEURO II-SE, MODELS: OR-DR-OR, OR-MB | May 22, 2007 |
| K061916 | NEURO II-SE, MODELS OR-MB-DR AND OR-DR | August 11, 2006 |