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
Declining activity -
15 submissions in the last 2 years
vs 23 in the prior period
Review times increasing: avg
84d
recently vs 62d historically
FDA 510(k) Cleared Coil, Magnetic Resonance, Specialty Devices (Product Code MOS)
488 devices
Cleared
Apr 23, 2026
0.55T 12Ch Breast Coil
Neocoil, LLC
Radiology
31d
Cleared
Apr 14, 2026
HD 8Ch Wrist Array
Shenzhen RF Tech Co., Ltd.
Radiology
242d
Cleared
Apr 01, 2026
GEM Flex Coil 16-L Array, 3.0T Receive Only
Shenzhen RF Tech Co., Ltd.
Radiology
203d
Cleared
Mar 20, 2026
Smart Fit TorsoCardiac 1.5T
Philips Healthcare (Suzhou) Co., Ltd.
Radiology
31d
Cleared
Feb 10, 2026
GEM Flex Coil 16-L Array, 1.5T Receive Only
Shenzhen RF Tech Co., Ltd.
Radiology
214d
Cleared
Jan 23, 2026
3.0T AIR 32CH HNA
Ge Healthcare Coils (Usa Instruments, Inc.)
Radiology
60d
Cleared
Jan 14, 2026
dS Base 1.5T
Philips Medical Systems Nederland B.V.
Radiology
22d
Cleared
Oct 20, 2025
InkSpace Imaging Small Body Array (SBA12PH30x)
Inkspace Imaging, Inc.
Radiology
24d
Cleared
Jul 17, 2025
e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
Dxtx Medical, Inc.
Radiology
254d
Cleared
Feb 28, 2025
16ch Flex SPEEDER Medium 1.5T (Q7000246)
Quality Electrodynamics
Radiology
59d
Cleared
Dec 20, 2024
InkSpace Imaging Small Body Array
Inkspace Imaging, Inc.
Radiology
23d
Cleared
Nov 19, 2024
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
Radiology
28d
Cleared
Oct 18, 2024
dS Knee Coil 8ch 1.5T
Philips Medical Systems Nederland B.V.
Radiology
25d
Cleared
Oct 18, 2024
dS Wrist coil 8ch 1.5T
Philips Medical Systems Nederland B.V.
Radiology
21d
Cleared
Aug 12, 2024
dS FootAnkle Coil 8ch 1.5T
Philips Medical Systems Nederland B.V.
Radiology
25d
Cleared
Jun 07, 2024
iLoop Interventional Coil 0.55T
Noras Mri Products GmbH
Radiology
49d
Cleared
Feb 16, 2024
Contour Hand/Wrist (Q7000232)
Quality Electrodynamics
Radiology
94d
Cleared
Feb 15, 2024
Contour Shoulder
Quality Electrodynamics
Radiology
93d
Cleared
Feb 05, 2024
Smart Fit Knee 3.0T
Philips Healthcare (Suzhou) Co., Ltd.
Radiology
88d
Cleared
Jan 08, 2024
InkSpace Imaging Small Body Array
Inkspace Imaging, Inc.
Radiology
81d
Cleared
Oct 24, 2023
16 Breast Coil
Philips Medical System Nederlands B.V.
Radiology
25d
Cleared
Oct 03, 2023
dS Breast Coil 7ch 1.5T
Invivo Corporation (Business Trade Name: Philips)
Radiology
25d
Cleared
Sep 01, 2023
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
Philips Healthcare (Suzhou) Co., Ltd.
Radiology
56d
Cleared
Aug 18, 2023
1.5T HD T/R Knee Array (10-F34127)
Shenzhen RF Tech Co., Ltd.
Radiology
123d
About Product Code MOS - Regulatory Context
510(k) Submission Activity
488 total 510(k) submissions under product code MOS since 1995, with 488 receiving FDA clearance (average review time: 63 days).
Submission volume has declined in recent years - 15 submissions in the last 24 months compared to 23 in the prior period.
FDA 510(k) Review Time - MOS Product Code
Recent submissions under MOS have taken an average of 84 days to reach a decision - up from 62 days historically. Manufacturers should account for longer review timelines in current project planning.
MOS devices are reviewed by the Radiology panel. Browse all Radiology devices →