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