FDA Product Code MOS: Coil, Magnetic Resonance, Specialty
Specialized MRI coils optimize image quality for specific anatomical regions. FDA product code MOS covers specialty magnetic resonance coils used in clinical and research MRI applications.
These surface, phased array, or volume coils are placed close to the anatomy of interest to improve signal-to-noise ratio and spatial resolution for dedicated applications including cardiac, breast, extremity, and neurovascular MRI.
MOS devices are Class II medical devices, regulated under 21 CFR 892.1000 and reviewed by the FDA Radiology panel.
Leading manufacturers include Usa Instruments, Inc., Mri Devices Corp. and Quality Electrodynamics, LLC.
490
Total
490
Cleared
63d
Avg days
1995
Since
490 devices
Cleared
Jul 31, 2014
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE
Neocoil, LLC
Radiology
24d
Cleared
Jul 11, 2014
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
Quality Electrodynamics, LLC
Radiology
84d
Cleared
May 12, 2014
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
Resonance Innovations, LLC
Radiology
63d
Cleared
May 08, 2014
16 CH MULTIPURPOSE COIL VARIETY
Noras Rontgen-Und Medizintechnik GmbH
Radiology
97d
Cleared
Feb 26, 2014
ST SENSE NV 8 ARRAY COIL
Resonance Innovations, LLC
Radiology
22d
Cleared
Jan 27, 2014
ATAMA SYSTEM
Monteris Medical,
Radiology
174d
Cleared
Jan 27, 2014
1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY
Resonance Innovations, LLC
Radiology
32d
Cleared
Dec 26, 2013
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE
Neocoil, LLC
Radiology
48d
Cleared
Jul 25, 2013
DUOFLEX COIL SUITE (1.5T)
Mr Instruments, Inc.
Radiology
132d
Cleared
May 20, 2013
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
Resonance Innovations, LLC
Radiology
87d
Cleared
Apr 10, 2013
SPINE COIL
Usa Paramed Medical Systems, Inc.
Radiology
128d
Cleared
Mar 28, 2013
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
Neocoil, LLC
Radiology
160d
Cleared
Feb 22, 2013
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
Wipro GE Healthcare Private, Ltd.
Radiology
84d
Cleared
Jan 11, 2013
1.5T GEM RT OPEN ARRAY
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology
77d
Cleared
Dec 27, 2012
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
Imris, Inc.
Radiology
86d
Cleared
Dec 21, 2012
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646
Invivo Corporation
Radiology
91d
Cleared
Dec 13, 2012
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
Philips Medical Systems
Radiology
30d
Cleared
Nov 02, 2012
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
Invivo Corporation
Radiology
64d
Cleared
Oct 25, 2012
GE 8CH FOOT ANKLE COIL
Ge Hangwei Medical Systems Co., Ltd.
Radiology
51d
Cleared
Sep 25, 2012
TOSHIBA 3T 32CH HEAD SPEEDER COIL,
Quality Electrodynamics
Radiology
27d
Cleared
Aug 17, 2012
OCTAVE SPEEDER HEAD
Toshiba Medical Systems Corporation, Japan
Radiology
49d
Cleared
Aug 17, 2012
OCTAVE SPEEDER SPINE
Toshiba Medical Systems Corporation, Japan
Radiology
49d
Cleared
Jun 15, 2012
1.5T 16CH FLEX SPEEDER LARGE
Neocoil, LLC
Radiology
39d
Cleared
Jun 12, 2012
MULTIARRAY KIT
Paramed S.R.L.
Radiology
48d