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 Medical Advances, Inc..

490
Total
490
Cleared
63d
Avg days
1995
Since
490 devices
73–96 of 490
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 Apr 05, 2010
S-SCAN, MODEL 9800020010
K100670
Esaote, S.P.A.
Radiology · 27d
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 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 05, 2006
ECHELON SHOULDER COIL
K062556
Hitachi Medical Systems America, Inc.
Radiology · 36d
Cleared Aug 18, 2006
HHF1 ECHELON MULTI-PURPOSE COIL
K061950
Hitachi Medical Systems America, Inc.
Radiology · 39d
Cleared May 05, 2006
OR HEAD COIL 1.5 T
K060758
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Mar 15, 2006
MEDRAD 3.0T ECOIL IMAGING SYSTEM
K060401
Medrad, Inc.
Radiology · 28d
Cleared Nov 17, 2005
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
K053042
Medrad, Inc.
Radiology · 20d
Cleared Nov 09, 2005
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
K052916
Usa Instruments, Inc.
Radiology · 23d
Cleared Nov 01, 2005
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
K052827
Medrad, Inc.
Radiology · 27d
Cleared Oct 07, 2005
1.5T 12 CHANNEL BODY ARRAY
K052584
Usa Instruments, Inc.
Radiology · 17d
Cleared Oct 07, 2005
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
K052621
Usa Instruments, Inc.
Radiology · 14d
Cleared Oct 04, 2005
3T HD BREAST ARRAY
K052585
Usa Instruments, Inc.
Radiology · 14d
Cleared Aug 16, 2005
G-SCAN CERVICAL SPINE COIL
K052077
Esaote, S.P.A.
Radiology · 15d
Cleared Jul 14, 2005
QD KNEE/FOOT COIL, MODEL MJQJ-147A
K051763
Toshiba America Medical Systems, In.C
Radiology · 14d