MOS · Class II · 21 CFR 892.1000

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
97–120 of 490
Cleared Jul 31, 2014
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE
K141832
Neocoil, LLC
Radiology · 24d
Cleared Jul 11, 2014
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
K140998
Quality Electrodynamics, LLC
Radiology · 84d
Cleared May 12, 2014
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
K140606
Resonance Innovations, LLC
Radiology · 63d
Cleared May 08, 2014
16 CH MULTIPURPOSE COIL VARIETY
K140252
Noras Rontgen-Und Medizintechnik GmbH
Radiology · 97d
Cleared Feb 26, 2014
ST SENSE NV 8 ARRAY COIL
K140282
Resonance Innovations, LLC
Radiology · 22d
Cleared Jan 27, 2014
ATAMA SYSTEM
K132444
Monteris Medical,
Radiology · 174d
Cleared Jan 27, 2014
1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY
K133986
Resonance Innovations, LLC
Radiology · 32d
Cleared Dec 26, 2013
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE
K133422
Neocoil, LLC
Radiology · 48d
Cleared Jul 25, 2013
DUOFLEX COIL SUITE (1.5T)
K130706
Mr Instruments, Inc.
Radiology · 132d
Cleared May 20, 2013
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
K130457
Resonance Innovations, LLC
Radiology · 87d
Cleared Apr 10, 2013
SPINE COIL
K123708
Usa Paramed Medical Systems, Inc.
Radiology · 128d
Cleared Mar 28, 2013
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
K123272
Neocoil, LLC
Radiology · 160d
Cleared Feb 22, 2013
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
K123681
Wipro GE Healthcare Private, Ltd.
Radiology · 84d
Cleared Jan 11, 2013
1.5T GEM RT OPEN ARRAY
K123327
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology · 77d
Cleared Dec 27, 2012
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
K123091
Imris, Inc.
Radiology · 86d
Cleared Dec 21, 2012
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646
K122897
Invivo Corporation
Radiology · 91d
Cleared Dec 13, 2012
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
K123492
Philips Medical Systems
Radiology · 30d
Cleared Nov 02, 2012
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
K122646
Invivo Corporation
Radiology · 64d
Cleared Oct 25, 2012
GE 8CH FOOT ANKLE COIL
K122694
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 51d
Cleared Sep 25, 2012
TOSHIBA 3T 32CH HEAD SPEEDER COIL,
K122638
Quality Electrodynamics
Radiology · 27d
Cleared Aug 17, 2012
OCTAVE SPEEDER HEAD
K121910
Toshiba Medical Systems Corporation, Japan
Radiology · 49d
Cleared Aug 17, 2012
OCTAVE SPEEDER SPINE
K121911
Toshiba Medical Systems Corporation, Japan
Radiology · 49d
Cleared Jun 15, 2012
1.5T 16CH FLEX SPEEDER LARGE
K121362
Neocoil, LLC
Radiology · 39d
Cleared Jun 12, 2012
MULTIARRAY KIT
K121249
Paramed S.R.L.
Radiology · 48d