IMRIS Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0144-2015Class IIIMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations oOctober 1, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K143420SYMBIS Surgical SystemOctober 30, 2015
K141950HFD100 ROCKER ARM ACCESSORYSeptember 4, 2014
K133692IMRI 1.5T AND IMRI 3T SFebruary 10, 2014
K130224ICTJuly 18, 2013
K123091VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3TDecember 27, 2012
K121997IMRIS ONCOLOGY PACKAGEAugust 10, 2012
K113748IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)March 23, 2012
K103493HEAD FIATION DEVICE (HFD 100)March 11, 2011
K1035061.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)February 2, 2011
K101813IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIOOctober 5, 2010
K091166IMRXSeptember 2, 2009
K083137NEURO III-SVDecember 16, 2008
K071099NEURO II-SE, MODELS: OR-DR-OR, OR-MBMay 22, 2007
K061916NEURO II-SE, MODELS OR-MB-DR AND OR-DRAugust 11, 2006