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 Shenzhen RF Tech Co., Ltd., Philips Medical Systems Nederland B.V. and Philips Healthcare (Suzhou) Co., Ltd..
FDA 510(k) Cleared Coil, Magnetic Resonance, Specialty Devices (Product Code MOS)
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 - 16 submissions in the last 24 months compared to 22 in the prior period.
FDA Review Time
Recent submissions under MOS have taken an average of 82 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 →