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 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
25–48 of 488
Cleared Jul 20, 2023
IGAR System (1001.A)
K223484
Insight Medbotics, Inc.
Radiology · 244d
Cleared Jun 29, 2023
XENOVIEW 3.0T Chest Coil
K231647
Polarean, Inc.
Radiology · 24d
Cleared Feb 14, 2023
8ch T/R Knee Coil
K223225
Shenzhen RF Tech Co., Ltd.
Radiology · 119d
Cleared Feb 01, 2023
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
K213480
Rapid Biomedical GmbH
Radiology · 460d
Cleared Jan 13, 2023
Contour Knee
K223429
Quality Electrodynamics, LLC
Radiology · 60d
Cleared Jan 03, 2023
3.0T 16ch AIR AA
K223378
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology · 57d
Cleared Dec 23, 2022
XENOVIEW 3.0T Chest Coil
K212239
Polarean, Inc.
Radiology · 522d
Cleared Dec 08, 2022
8ch Wrist Coil
K223239
Shenzhen RF Tech Co., Ltd.
Radiology · 49d
Cleared Dec 08, 2022
InkSpace Imaging Body Array
K223487
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
K222407
Neocoil, LLC
Radiology · 66d
Cleared Aug 31, 2022
8ch Wrist Coil
K222325
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
K222257
Invivo Corporation (Business Trade Name: Philips)
Radiology · 27d
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 3.0T Coil
K213727
Invivo Corporation (Business Trade Name: Philips)
Radiology · 255d
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 1.5T Coil
K213735
Invivo Corporation (Business Trade Name: Philips)
Radiology · 252d
Cleared Apr 08, 2022
Breast BI Coil Set 0.55T
K220144
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
K213687
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
K211658
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
K213766
Invivo Corporation
Radiology · 22d
Cleared Dec 17, 2021
InkSpace Imaging Pediatric Body Array
K213397
Inkspace Imaging, Inc.
Radiology · 60d
Cleared Dec 01, 2021
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
K212864
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 84d
Cleared Oct 29, 2021
ds Head 32ch 3.0T
K213351
Invivo Corporation (Business Trade Name: Philips)
Radiology · 21d
Cleared Jul 22, 2020
8ch Flex Suite
K200836
Shenzhen RF Tech Co., Ltd.
Radiology · 113d
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