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
49–72 of 490
Cleared Jun 02, 2020
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
K201101
Neocoil, LLC
Radiology · 39d
Cleared Apr 08, 2020
Flex Body Speeder
K200477
Quality Electrodynamics, LLC
Radiology · 41d
Cleared Jan 31, 2020
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
K191539
Rapid Biomedical GmbH
Radiology · 235d
Cleared Jan 03, 2020
Flex Body SPEEDER
K193140
Quality Electrodynamics, LLC
Radiology · 51d
Cleared Sep 09, 2019
Encompass 15 Channel Head Coil, 3T
K190668
Qfix
Radiology · 178d
Cleared Apr 12, 2019
3T 32 Channel Head Coil
K182737
Nova Medical, Inc.
Radiology · 196d
Cleared Feb 08, 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24
K183186
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 81d
Cleared Dec 07, 2018
Contour 24
K183111
Quality Electrodynamics, LLC
Radiology · 29d
Cleared Nov 16, 2018
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
K181948
Rapid Biomedical GmbH
Radiology · 119d
Cleared Nov 16, 2018
1.5T 16ch Breast Coil
K182958
Neocoil, LLC
Radiology · 23d
Cleared Oct 19, 2018
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
K182590
Ge Healthcare
Radiology · 29d
Cleared Oct 12, 2018
3.0T Air MP M, 3.0T Air MP L
K182504
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology · 30d
Cleared Jul 11, 2018
16ch Foot/ Ankle SPEEDER
K181697
Quality Electrodynamics, LLC
Radiology · 14d
Cleared Apr 12, 2018
48CH Head Coil
K180666
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology · 29d
Cleared Mar 21, 2018
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
K163661
Rapid Biomedical GmbH
Radiology · 449d
Cleared Feb 16, 2018
Breast BI 7 MR Coil 1.5T Mammavention
K180123
Noras Mri Products GmbH
Radiology · 31d
Cleared Jan 09, 2018
16ch T/R Hand Wrist Coil
K173469
Quality Electrodynamics, LLC
Radiology · 62d
Cleared Sep 16, 2016
TRILLIUM Oval Head Coil 32
K162079
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Dec 13, 2012
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
K123492
Philips Medical Systems
Radiology · 30d
Cleared Apr 06, 2011
TEMPOROMANIBULAR COIL 15
K110373
Esaote, S.P.A.
Radiology · 57d
Cleared Apr 01, 2011
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
K110610
Ge Medical Systems, LLC
Radiology · 29d
Cleared Mar 07, 2011
GEM OPTION FOR 1.5 MRI SYSTEMS
K103335
Ge Healthcare
Radiology · 112d
Cleared Feb 25, 2011
ECHELON RAPID CARDIAC COIL
K110120
Hitachi Medical Systems America, Inc.
Radiology · 38d
Cleared Jan 11, 2011
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
K103275
Siemens Medical Solutions USA, Inc.
Radiology · 67d