FDA 510(k) Applications Submitted by IMRIS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130224 |
01/29/2013 |
ICT |
IMRIS, INC. |
| K141950 |
07/18/2014 |
HFD100 ROCKER ARM ACCESSORY |
IMRIS, INC. |
| K121997 |
07/09/2012 |
IMRIS ONCOLOGY PACKAGE |
IMRIS, INC. |
| K123091 |
10/02/2012 |
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T |
IMRIS, INC. |
| K143420 |
11/28/2014 |
SYMBIS Surgical System |
IMRIS, Inc. |
| K133692 |
12/02/2013 |
IMRI 1.5T AND IMRI 3T S |
IMRIS, INC. |
| K113748 |
12/21/2011 |
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) |
IMRIS, INC. |
| K103506 |
11/29/2010 |
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) |
IMRIS, INC. |
| K071099 |
04/19/2007 |
NEURO II-SE, MODELS: OR-DR-OR, OR-MB |
IMRIS, INC. |
| K091166 |
04/22/2009 |
IMRX |
IMRIS, INC. |
| K101813 |
06/29/2010 |
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO |
IMRIS, INC. |
| K061916 |
07/06/2006 |
NEURO II-SE, MODELS OR-MB-DR AND OR-DR |
IMRIS, INC. |
| K083137 |
10/23/2008 |
NEURO III-SV |
IMRIS, INC. |
| K103493 |
11/29/2010 |
HEAD FIATION DEVICE (HFD 100) |
IMRIS, INC. |
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