Company ยท US
Imris, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2015. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 30, 2015 | K143420 | SYMBIS Surgical System Imris, Inc. | HAW |
| Sep 4, 2014 | K141950 | HFD100 ROCKER ARM ACCESSORY Imris, Inc. | HBL |
| Feb 10, 2014 | K133692 | IMRI 1.5T AND IMRI 3T S Imris, Inc. | LNH |
| Jul 18, 2013 | K130224 | ICT Imris, Inc., CA | JAK |
| Dec 27, 2012 | K123091 | VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T Imris, Inc., CA | MOS |
| Aug 10, 2012 | K121997 | IMRIS ONCOLOGY PACKAGE Imris, Inc., CA | LNH |
| Mar 23, 2012 | K113748 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) Imris, Inc., CA | HBL |
| Mar 11, 2011 | K103493 | HEAD FIATION DEVICE (HFD 100) Imris, Inc. | HBL |
| Feb 2, 2011 | K103506 | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) Imris, Inc. | MOS |
| Oct 5, 2010 | K101813 | IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO Imris, Inc. | LNH |
| Sep 2, 2009 | K091166 | IMRX Imris, Inc. | LNH |
| Dec 16, 2008 | K083137 | NEURO III-SV Imris, Inc. | LNH |
| May 22, 2007 | K071099 | NEURO II-SE, MODELS: OR-DR-OR, OR-MB Imris, Inc. | LNH |
| Aug 11, 2006 | K061916 | NEURO II-SE, MODELS OR-MB-DR AND OR-DR Imris, Inc. | LNH |