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
121–144 of 490
Cleared Mar 29, 2012
INFANT ARRAY
K113365
Advanced Imaging Research Dba Sree Medical Systems
Radiology · 135d
Cleared Mar 29, 2012
TOSHIBA 1.5T QD HEAD COIL
K120627
Quality Electrodynamics
Radiology · 28d
Cleared Mar 16, 2012
1.5T GEM FLEX COIL
K113474
Neocoil, LLC
Radiology · 115d
Cleared Feb 28, 2012
TOSHIBA 1.5T CARDIAC COIL
K120290
Quality Electrodynamics
Radiology · 28d
Cleared Feb 10, 2012
SENSE MSK S 8CH 1.5T
K120122
Invivo Corporation
Radiology · 24d
Cleared Dec 23, 2011
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
K111673
Invivo Corporation
Radiology · 191d
Cleared Nov 23, 2011
CAROTID COIL GE 1.5T
K113280
Tursiop Technologies, LLC
Radiology · 16d
Cleared Nov 18, 2011
CAROTID COIL
K112002
Shanghai Chenguang Medical Technologies Co, Ltd.
Radiology · 128d
Cleared Sep 30, 2011
HTS EXTREMITY COIL, HTS SURFACE COIL
K112293
Time Medical Systems, Inc.
Radiology · 51d
Cleared Sep 15, 2011
4CH FLEX SPEEDER
K112366
Toshiba Medical Systems Coporation, Japan
Radiology · 29d
Cleared Sep 09, 2011
MRGFUS PELVIC PA COIL MODEL 1.0
K111060
Insightech, Ltd.
Radiology · 144d
Cleared Sep 09, 2011
TOSHIBA 3T EXTRA LARGE KNEE COIL
K112313
Quality Electrodynamics
Radiology · 29d
Cleared Sep 08, 2011
SV BRAIN ARRAY, SIEMENS 3T
K111802
Mri Interventions, Inc.
Radiology · 73d
Cleared Aug 25, 2011
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
K112112
Sentinel Medical, Inc.
Radiology · 31d
Cleared Aug 18, 2011
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
K103274
Sentinelle Medical, Inc.
Radiology · 286d
Cleared Jul 05, 2011
SV DBS VRAIN ARRAY
K111259
Midwest Rf, LLC
Radiology · 62d
Cleared May 27, 2011
4CH FLEX SPEEDER
K111251
Toshiba Medical Systems Coporation, Japan
Radiology · 23d
Cleared Apr 19, 2011
FLEXIBLE CARDIAC COIL
K110487
Lbds Holding Company
Radiology · 56d
Cleared Apr 08, 2011
ATAMA SYSTEM
K110411
Monteris Medical, Inc.
Radiology · 53d
Cleared Apr 06, 2011
TEMPOROMANIBULAR COIL 15
K110373
Esaote, S.P.A.
Radiology · 57d
Cleared Apr 01, 2011
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
K110610
Ge Medical Systems, LLC
Radiology · 29d
Cleared Mar 29, 2011
MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
K110591
Mr Instruments, Inc.
Radiology · 27d
Cleared Mar 07, 2011
GEM OPTION FOR 1.5 MRI SYSTEMS
K103335
Ge Healthcare
Radiology · 112d
Cleared Feb 25, 2011
ECHELON RAPID CARDIAC COIL
K110120
Hitachi Medical Systems America, Inc.
Radiology · 38d