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
73–96 of 490
Cleared Jan 12, 2017
48CH Head Coil
K163205
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology · 58d
Cleared Jan 06, 2017
8ch Knee-Foot SPEEDER
K162946
Quality Electrodynamics, LLC
Radiology · 77d
Cleared Dec 09, 2016
16ch T/R Hand Wrist Coil
K162623
Quality Electrodynamics, LLC
Radiology · 80d
Cleared Nov 30, 2016
TxRx Knee 15 Flare MR Coil 1.5T
K162966
Quality Electrodynamics, LLC
Radiology · 37d
Cleared Nov 29, 2016
TxRx Knee 15 Flare MR Coil 3.0T
K163066
Quality Electrodynamics, LLC
Radiology · 27d
Cleared Nov 07, 2016
dS Small Extremity 16CH 1.5T Coil
K162863
Invivo Therapeutics Corporation
Radiology · 25d
Cleared Oct 18, 2016
16ch T/R Knee Coil
K162029
Quality Electrodynamics, LLC
Radiology · 88d
Cleared Sep 16, 2016
TRILLIUM Oval Head Coil 32
K162079
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Sep 14, 2016
dS FootAnkle I6CH 1.5T Coil
K162177
Invivo Corporation
Radiology · 41d
Cleared Aug 31, 2016
1.5T and 3.0T 16 CH GE Shoulder Coils
K162001
Invivo Corporation
Radiology · 42d
Cleared Aug 01, 2016
8ch Foot Ankle Coil
K160932
Shenzhen RF Tech Co., Ltd.
Radiology · 119d
Cleared Jul 28, 2016
8ch Foot Ankle Coil
K160935
Shenzhen RF Tech Co., Ltd.
Radiology · 115d
Cleared Jun 02, 2016
16ch Tx/Rx Knee SPEEDER
K161193
Quality Electrodynamics, LLC
Radiology · 36d
Cleared Nov 18, 2015
8 CH Knee SPEEDER
K152695
Quality Electrodynamics, LLC
Radiology · 58d
Cleared Aug 27, 2015
16 ch Tx/Rx Knee SPEEDER
K151753
Quality Electrodynamics, LLC
Radiology · 59d
Cleared Aug 07, 2015
8ch Foot Ankle Coil
K151653
Shenzhen RF Tech Co., Ltd.
Radiology · 50d
Cleared Jul 29, 2015
Atlas SPEEDER Header/Neck
K151829
Quality Electrodynamics, LLC
Radiology · 23d
Cleared Apr 09, 2015
18ch T/R Knee Coil
K150331
Quality Electrodynamics, LLC
Radiology · 58d
Cleared Mar 06, 2015
3.0T GEM RT Open Array
K143389
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology · 100d
Cleared Dec 05, 2014
Siemens 3.0T PROCURE Array Coil
K142676
Resonance Innovations, LLC
Radiology · 77d
Cleared Nov 24, 2014
Atlas SPEEDER Head/Neck
K142802
Quality Electrodynamics, LLC
Radiology · 56d
Cleared Oct 23, 2014
Siemens 3.0 Blanket Array Coil
K142755
Resonance Innovations, LLC
Radiology · 28d
Cleared Aug 22, 2014
BREAST SPEEDER CX, GRID HOLDER CX
K142002
Quality Electrodynamics, LLC
Radiology · 30d
Cleared Aug 06, 2014
NORAS OR HEAD HOLDER FLEXIBILITY
K133506
Noras Mri Products GmbH
Radiology · 265d