Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1000](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1000) → MOS — Coil, Magnetic Resonance, Specialty # MOS · Coil, Magnetic Resonance, Specialty _Radiology · 21 CFR 892.1000 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS ## Overview - **Product Code:** MOS - **Device Name:** Coil, Magnetic Resonance, Specialty - **Regulation:** [21 CFR 892.1000](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1000) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K252587.md) | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | Apr 14, 2026 | SESE | | [K252876](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K252876.md) | 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K260519.md) | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | Mar 20, 2026 | SESE | | [K252179](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K252179.md) | 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K253738.md) | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | Jan 23, 2026 | SESE | | [K254190](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K254190.md) | 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K253182.md) | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | Oct 20, 2025 | SESE | | [K243428](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K243428.md) | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. | Jul 17, 2025 | SESE | | [K244054](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K244054.md) | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics | Feb 28, 2025 | SESE | | [K243675](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K243675.md) | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | Dec 20, 2024 | SESE | | [K243316](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K243316.md) | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | Nov 19, 2024 | SESE | | [K243033](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K243033.md) | dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | Oct 18, 2024 | SESE | | [K242879](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K242879.md) | dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | Oct 18, 2024 | SESE | | [K242096](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K242096.md) | dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | Aug 12, 2024 | SESE | | [K241069](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K241069.md) | iLoop Interventional Coil 0.55T | Noras Mri Products GmbH | Jun 7, 2024 | SESE | | [K233652](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K233652.md) | Contour Hand/Wrist (Q7000232) | Quality Electrodynamics | Feb 16, 2024 | SESE | | [K233656](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K233656.md) | Contour Shoulder | Quality Electrodynamics | Feb 15, 2024 | SESE | | [K233600](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K233600.md) | Smart Fit Knee 3.0T | Philips Healthcare (Suzhou) Co., Ltd. | Feb 5, 2024 | SESE | | [K233444](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K233444.md) | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | Jan 8, 2024 | SESE | | [K233348](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K233348.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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