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) → LNH — System, Nuclear Magnetic Resonance Imaging # LNH · System, Nuclear Magnetic Resonance Imaging _Radiology · 21 CFR 892.1000 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH ## Overview - **Product Code:** LNH - **Device Name:** System, Nuclear Magnetic Resonance Imaging - **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 1098) Showing 20 most recent of 1098 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253862](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K253862.md) | APERTO Lucent MRI System | Fujifilm Corporation | Apr 6, 2026 | SESE | | [K260746](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K260746.md) | S-scan Open (100001800) | Esaote, S.p.A. | Mar 27, 2026 | SESE | | [K253625](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K253625.md) | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | Mar 27, 2026 | SESE | | [K251937](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K251937.md) | nordicAudio (1.0) | Nordicneurolab AS | Mar 20, 2026 | SESE | | [K254277](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K254277.md) | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | Mar 13, 2026 | SESE | | [K253413](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K253413.md) | LiverMultiScan (v6.0) | Perspectum, Ltd. | Mar 9, 2026 | SESE | | [K251901](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K251901.md) | Magnifico Open (100009900) | Esaote, S.p.A. | Mar 5, 2026 | SESE | | [K260265](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K260265.md) | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | Feb 23, 2026 | SESE | | [K253648](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K253648.md) | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. | Feb 23, 2026 | SESE | | [K253780](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K253780.md) | SIGNA™ Bolt | Ge Medical Systems, LLC | Feb 6, 2026 | SESE | | [K253779](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K253779.md) | SIGNA™ Sprint Select | Ge Medical Systems, LLC | Feb 5, 2026 | SESE | | [K253499](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K253499.md) | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | Jan 26, 2026 | SESE | | [K252379](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K252379.md) | AIR Recon DL | Ge Medical Systems, LLC | Dec 23, 2025 | SESE | | [K252838](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K252838.md) | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Siemens Healthcare GmbH | Dec 19, 2025 | SESE | | [K253489](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K253489.md) | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | Dec 12, 2025 | SESE | | [K251822](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K251822.md) | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | Nov 20, 2025 | SESE | | [K252371](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K252371.md) | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | Sep 25, 2025 | SESE | | [K251386](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K251386.md) | ECHELON Synergy | Fujifilm Corporation | Sep 17, 2025 | SESE | | [K251399](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K251399.md) | SIGNA™ Sprint | Ge Medical Systems, LLC | Sep 11, 2025 | SESE | | [K251682](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K251682.md) | MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) | Sep 9, 2025 | SESE | ## Top Applicants - Siemens Medical Solutions USA, Inc. — 135 clearances - Toshiba America Mri, Inc. — 62 clearances - Philips Medical Systems (Cleveland), Inc. — 57 clearances - Hitachi Medical Systems America, Inc. — 54 clearances - GE Medical Systems — 39 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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