MOS · Coil, Magnetic Resonance, Specialty
Radiology · 21 CFR 892.1000 · Class 2
Overview
| Product Code | MOS |
|---|---|
| Device Name | Coil, Magnetic Resonance, Specialty |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
Classification Rationale
Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 487)
Showing 20 most recent of 487 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | Apr 14, 2026 | SESE |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | Shenzhen RF Tech Co., Ltd. | Apr 1, 2026 | SESE |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | Mar 20, 2026 | SESE |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only | Shenzhen RF Tech Co., Ltd. | Feb 10, 2026 | SESE |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | Jan 23, 2026 | SESE |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | Philips Medical Systems Nederland B.V. | Jan 14, 2026 | SESE |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | Oct 20, 2025 | SESE |
| K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. | Jul 17, 2025 | SESE |
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics | Feb 28, 2025 | SESE |
| K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | Dec 20, 2024 | SESE |
| K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | Nov 19, 2024 | SESE |
| K243033 | dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | Oct 18, 2024 | SESE |
| K242879 | dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | Oct 18, 2024 | SESE |
| K242096 | dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | Aug 12, 2024 | SESE |
| K241069 | iLoop Interventional Coil 0.55T | Noras Mri Products GmbH | Jun 7, 2024 | SESE |
| K233652 | Contour Hand/Wrist (Q7000232) | Quality Electrodynamics | Feb 16, 2024 | SESE |
| K233656 | Contour Shoulder | Quality Electrodynamics | Feb 15, 2024 | SESE |
| K233600 | Smart Fit Knee 3.0T | Philips Healthcare (Suzhou) Co., Ltd. | Feb 5, 2024 | SESE |
| K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | Jan 8, 2024 | SESE |
| K233348 | 16 Breast Coil | Philips Medical System Nederlands B.V. | Oct 24, 2023 | SESE |
Top Applicants
- Usa Instruments, Inc. — 63 clearances
- Mri Devices Corp. — 60 clearances
- Quality Electrodynamics, LLC — 20 clearances
- Medical Advances, Inc. — 19 clearances
- Hitachi Medical Systems America, Inc. — 18 clearances
