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
Jul 20, 2023
IGAR System (1001.A)
Insight Medbotics, Inc.
Radiology
244d
Cleared
Jun 29, 2023
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
Radiology
24d
Cleared
Feb 14, 2023
8ch T/R Knee Coil
Shenzhen RF Tech Co., Ltd.
Radiology
119d
Cleared
Feb 01, 2023
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
Rapid Biomedical GmbH
Radiology
460d
Cleared
Jan 13, 2023
Contour Knee
Quality Electrodynamics, LLC
Radiology
60d
Cleared
Jan 03, 2023
3.0T 16ch AIR AA
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology
57d
Cleared
Dec 23, 2022
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
Radiology
522d
Cleared
Dec 08, 2022
8ch Wrist Coil
Shenzhen RF Tech Co., Ltd.
Radiology
49d
Cleared
Dec 08, 2022
InkSpace Imaging Body Array
Inkspace Imaging, Inc.
Radiology
17d
Cleared
Oct 14, 2022
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
Neocoil, LLC
Radiology
66d
Cleared
Aug 31, 2022
8ch Wrist Coil
Invivo Corporation (Business Trade Name: Philips)
Radiology
29d
Cleared
Aug 23, 2022
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
Invivo Corporation (Business Trade Name: Philips)
Radiology
27d
Cleared
Aug 08, 2022
dS Sentinelle Breast 16ch 3.0T Coil
Invivo Corporation (Business Trade Name: Philips)
Radiology
255d
Cleared
Aug 08, 2022
dS Sentinelle Breast 16ch 1.5T Coil
Invivo Corporation (Business Trade Name: Philips)
Radiology
252d
Cleared
Apr 08, 2022
Breast BI Coil Set 0.55T
Noras Mri Products GmbH
Radiology
79d
Cleared
Mar 11, 2022
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
Neocoil, LLC
Radiology
108d
Cleared
Mar 03, 2022
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T
Noras Mri Products GmbH
Radiology
279d
Cleared
Dec 23, 2021
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
Invivo Corporation
Radiology
22d
Cleared
Dec 17, 2021
InkSpace Imaging Pediatric Body Array
Inkspace Imaging, Inc.
Radiology
60d
Cleared
Dec 01, 2021
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
Philips Healthcare (Suzhou) Co., Ltd.
Radiology
84d
Cleared
Oct 29, 2021
ds Head 32ch 3.0T
Invivo Corporation (Business Trade Name: Philips)
Radiology
21d
Cleared
Jul 22, 2020
8ch Flex Suite
Shenzhen RF Tech Co., Ltd.
Radiology
113d
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