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 Siemens Medical Solutions USA, Inc., Shenzhen RF Tech Co., Ltd. and Invivo Corporation (Business Trade Name: Philips).
488
Total
488
Cleared
63d
Avg days
1995
Since
488 devices
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
Jan 11, 2011
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
Siemens Medical Solutions USA, Inc.
Radiology
67d
Cleared
Aug 27, 2010
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
Siemens Medical Solutions USA, Inc.
Radiology
220d
Cleared
Jan 13, 2009
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
Siemens Medical Solutions USA, Inc.
Radiology
78d
Cleared
Jun 13, 2007
NORAS OR HEAD HOLDER
Siemens Medical Solutions USA, Inc.
Radiology
47d
Cleared
May 05, 2006
OR HEAD COIL 1.5 T
Siemens Medical Solutions USA, Inc.
Radiology
45d
Cleared
Nov 05, 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
Siemens Medical Solutions USA, Inc.
Radiology
42d
Cleared
Feb 04, 2000
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
44d
Cleared
Dec 05, 1997
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
72d