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
145–168 of 490
Cleared Feb 02, 2011
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
K103506
Imris, Inc.
Radiology · 65d
Cleared Jan 12, 2011
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR)
K103365
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology · 56d
Cleared Jan 11, 2011
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
K103275
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Jan 03, 2011
1.5T 16-CHANNEL HAND-WRIST COIL
K103149
Invivo Corporation
Radiology · 70d
Cleared Dec 23, 2010
3.0T METAFLEXCOIL
K103342
Neocoil, LLC
Radiology · 38d
Cleared Dec 20, 2010
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
K102889
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Aug 27, 2010
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
K100141
Siemens Medical Solutions USA, Inc.
Radiology · 220d
Cleared Aug 24, 2010
METAFLEXCOIL
K101632
Neocoil, LLC
Radiology · 75d
Cleared Apr 05, 2010
S-SCAN, MODEL 9800020010
K100670
Esaote, S.P.A.
Radiology · 27d
Cleared Mar 05, 2010
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
K093842
Invivo Corporation
Radiology · 80d
Cleared Feb 01, 2010
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
K093284
Invivo Corporation
Radiology · 104d
Cleared Jan 13, 2009
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Dec 05, 2008
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
K083086
Hitachi Medical Systems America, Inc.
Radiology · 50d
Cleared Oct 17, 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K083014
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Aug 12, 2008
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
K081745
Hitachi Medical Systems America, Inc.
Radiology · 54d
Cleared Jun 18, 2008
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N
K081198
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Feb 11, 2008
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
K080062
Hitachi Medical Systems America, Inc.
Radiology · 33d
Cleared Nov 21, 2007
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL
K073181
Neocoil, LLC
Radiology · 8d
Cleared Oct 31, 2007
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
K072909
Siemens AG Medical Solutions
Radiology · 19d
Cleared Jun 13, 2007
NORAS OR HEAD HOLDER
K071179
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Dec 12, 2006
ECHELON MR-RCC-150 CARDIAC COIL
K063513
Hitachi Medical Systems America, Inc.
Radiology · 21d
Cleared Nov 30, 2006
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
K063342
Medrad, Inc.
Radiology · 24d
Cleared Oct 13, 2006
CTL-63 AND CTL-128 SPINE ARRAY COILS
K062767
Invivo Corporation
Radiology · 28d
Cleared Oct 05, 2006
ECHELON SHOULDER COIL
K062556
Hitachi Medical Systems America, Inc.
Radiology · 36d