Imris, Inc. - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
11 devices
Cleared
Feb 10, 2014
IMRI 1.5T AND IMRI 3T S
Radiology
70d
Cleared
Jul 18, 2013
ICT
Radiology
170d
Cleared
Dec 27, 2012
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
Radiology
86d
Cleared
Aug 10, 2012
IMRIS ONCOLOGY PACKAGE
Radiology
32d
Cleared
Mar 23, 2012
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
Radiology
93d
Cleared
Feb 02, 2011
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
Radiology
65d
Cleared
Oct 05, 2010
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
Radiology
98d
Cleared
Sep 02, 2009
IMRX
Radiology
133d
Cleared
Dec 16, 2008
NEURO III-SV
Radiology
54d
Cleared
May 22, 2007
NEURO II-SE, MODELS: OR-DR-OR, OR-MB
Radiology
33d
Cleared
Aug 11, 2006
NEURO II-SE, MODELS OR-MB-DR AND OR-DR
Radiology
36d