LNH · System, Nuclear Magnetic Resonance Imaging
Radiology · 21 CFR 892.1000 · Class 2
Overview
| Product Code | LNH |
|---|---|
| Device Name | System, Nuclear Magnetic Resonance Imaging |
| 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 1098)
Showing 20 most recent of 1098 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | Apr 6, 2026 | SESE |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | Mar 27, 2026 | SESE |
| K253625 | 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 | nordicAudio (1.0) | Nordicneurolab AS | Mar 20, 2026 | SESE |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | Mar 13, 2026 | SESE |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | Mar 9, 2026 | SESE |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | Mar 5, 2026 | SESE |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | Feb 23, 2026 | SESE |
| K253648 | 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 | SIGNA Bolt | Ge Medical Systems, LLC | Feb 6, 2026 | SESE |
| K253779 | SIGNA Sprint Select | Ge Medical Systems, LLC | Feb 5, 2026 | SESE |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | Jan 26, 2026 | SESE |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | Dec 23, 2025 | SESE |
| K252838 | 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 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | Dec 12, 2025 | SESE |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | Nov 20, 2025 | SESE |
| K252371 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | Sep 25, 2025 | SESE |
| K251386 | ECHELON Synergy | Fujifilm Corporation | Sep 17, 2025 | SESE |
| K251399 | SIGNA Sprint | Ge Medical Systems, LLC | Sep 11, 2025 | SESE |
| K251682 | 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
