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
Cleared
Jun 02, 2020
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
Neocoil, LLC
Radiology
39d
Cleared
Apr 08, 2020
Flex Body Speeder
Quality Electrodynamics, LLC
Radiology
41d
Cleared
Jan 31, 2020
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
Rapid Biomedical GmbH
Radiology
235d
Cleared
Jan 03, 2020
Flex Body SPEEDER
Quality Electrodynamics, LLC
Radiology
51d
Cleared
Sep 09, 2019
Encompass 15 Channel Head Coil, 3T
Qfix
Radiology
178d
Cleared
Apr 12, 2019
3T 32 Channel Head Coil
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
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
81d
Cleared
Dec 07, 2018
Contour 24
Quality Electrodynamics, LLC
Radiology
29d
Cleared
Nov 16, 2018
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
Rapid Biomedical GmbH
Radiology
119d
Cleared
Nov 16, 2018
1.5T 16ch Breast Coil
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
Ge Healthcare
Radiology
29d
Cleared
Oct 12, 2018
3.0T Air MP M, 3.0T Air MP L
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology
30d
Cleared
Jul 11, 2018
16ch Foot/ Ankle SPEEDER
Quality Electrodynamics, LLC
Radiology
14d
Cleared
Apr 12, 2018
48CH Head Coil
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology
29d
Cleared
Mar 21, 2018
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
Rapid Biomedical GmbH
Radiology
449d
Cleared
Feb 16, 2018
Breast BI 7 MR Coil 1.5T Mammavention
Noras Mri Products GmbH
Radiology
31d
Cleared
Jan 09, 2018
16ch T/R Hand Wrist Coil
Quality Electrodynamics, LLC
Radiology
62d
Cleared
Sep 16, 2016
TRILLIUM Oval Head Coil 32
Hitachi Medical Systems America, Inc.
Radiology
51d
Cleared
Dec 13, 2012
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
Philips Medical Systems
Radiology
30d
Cleared
Apr 06, 2011
TEMPOROMANIBULAR COIL 15
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
Ge Medical Systems, LLC
Radiology
29d
Cleared
Mar 07, 2011
GEM OPTION FOR 1.5 MRI SYSTEMS
Ge Healthcare
Radiology
112d
Cleared
Feb 25, 2011
ECHELON RAPID CARDIAC COIL
Hitachi Medical Systems America, Inc.
Radiology
38d
Cleared
Jan 11, 2011
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
Siemens Medical Solutions USA, Inc.
Radiology
67d