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
Mar 29, 2012
INFANT ARRAY
Advanced Imaging Research Dba Sree Medical Systems
Radiology
135d
Cleared
Mar 29, 2012
TOSHIBA 1.5T QD HEAD COIL
Quality Electrodynamics
Radiology
28d
Cleared
Mar 16, 2012
1.5T GEM FLEX COIL
Neocoil, LLC
Radiology
115d
Cleared
Feb 28, 2012
TOSHIBA 1.5T CARDIAC COIL
Quality Electrodynamics
Radiology
28d
Cleared
Feb 10, 2012
SENSE MSK S 8CH 1.5T
Invivo Corporation
Radiology
24d
Cleared
Dec 23, 2011
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
Invivo Corporation
Radiology
191d
Cleared
Nov 23, 2011
CAROTID COIL GE 1.5T
Tursiop Technologies, LLC
Radiology
16d
Cleared
Nov 18, 2011
CAROTID COIL
Shanghai Chenguang Medical Technologies Co, Ltd.
Radiology
128d
Cleared
Sep 30, 2011
HTS EXTREMITY COIL, HTS SURFACE COIL
Time Medical Systems, Inc.
Radiology
51d
Cleared
Sep 15, 2011
4CH FLEX SPEEDER
Toshiba Medical Systems Coporation, Japan
Radiology
29d
Cleared
Sep 09, 2011
MRGFUS PELVIC PA COIL MODEL 1.0
Insightech, Ltd.
Radiology
144d
Cleared
Sep 09, 2011
TOSHIBA 3T EXTRA LARGE KNEE COIL
Quality Electrodynamics
Radiology
29d
Cleared
Sep 08, 2011
SV BRAIN ARRAY, SIEMENS 3T
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
Sentinel Medical, Inc.
Radiology
31d
Cleared
Aug 18, 2011
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
Sentinelle Medical, Inc.
Radiology
286d
Cleared
Jul 05, 2011
SV DBS VRAIN ARRAY
Midwest Rf, LLC
Radiology
62d
Cleared
May 27, 2011
4CH FLEX SPEEDER
Toshiba Medical Systems Coporation, Japan
Radiology
23d
Cleared
Apr 19, 2011
FLEXIBLE CARDIAC COIL
Lbds Holding Company
Radiology
56d
Cleared
Apr 08, 2011
ATAMA SYSTEM
Monteris Medical, Inc.
Radiology
53d
Cleared
Apr 06, 2011
TEMPOROMANIBULAR COIL 15
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
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
Mr Instruments, Inc.
Radiology
27d
Cleared
Mar 07, 2011
GEM OPTION FOR 1.5 MRI SYSTEMS
Ge Healthcare
Radiology
112d
Cleared
Feb 25, 2011
ECHELON RAPID CARDIAC COIL
Hitachi Medical Systems America, Inc.
Radiology
38d