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
Feb 02, 2011
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
Imris, Inc.
Radiology
65d
Cleared
Jan 12, 2011
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR)
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology
56d
Cleared
Jan 11, 2011
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
Siemens Medical Solutions USA, Inc.
Radiology
67d
Cleared
Jan 03, 2011
1.5T 16-CHANNEL HAND-WRIST COIL
Invivo Corporation
Radiology
70d
Cleared
Dec 23, 2010
3.0T METAFLEXCOIL
Neocoil, LLC
Radiology
38d
Cleared
Dec 20, 2010
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
Hitachi Medical Systems America, Inc.
Radiology
81d
Cleared
Aug 27, 2010
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
Siemens Medical Solutions USA, Inc.
Radiology
220d
Cleared
Aug 24, 2010
METAFLEXCOIL
Neocoil, LLC
Radiology
75d
Cleared
Apr 05, 2010
S-SCAN, MODEL 9800020010
Esaote, S.P.A.
Radiology
27d
Cleared
Mar 05, 2010
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
Invivo Corporation
Radiology
80d
Cleared
Feb 01, 2010
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
Invivo Corporation
Radiology
104d
Cleared
Jan 13, 2009
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
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)
Hitachi Medical Systems America, Inc.
Radiology
50d
Cleared
Oct 17, 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
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
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
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
Hitachi Medical Systems America, Inc.
Radiology
33d
Cleared
Nov 21, 2007
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL
Neocoil, LLC
Radiology
8d
Cleared
Oct 31, 2007
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
Siemens AG Medical Solutions
Radiology
19d
Cleared
Jun 13, 2007
NORAS OR HEAD HOLDER
Siemens Medical Solutions USA, Inc.
Radiology
47d
Cleared
Dec 12, 2006
ECHELON MR-RCC-150 CARDIAC COIL
Hitachi Medical Systems America, Inc.
Radiology
21d
Cleared
Nov 30, 2006
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
Medrad, Inc.
Radiology
24d
Cleared
Oct 13, 2006
CTL-63 AND CTL-128 SPINE ARRAY COILS
Invivo Corporation
Radiology
28d
Cleared
Oct 05, 2006
ECHELON SHOULDER COIL
Hitachi Medical Systems America, Inc.
Radiology
36d