100 devices · 35 companies · 2008 to 2026
Product code LNH: System, Nuclear Magnetic Resonance Imaging
100 devices under product code LNH, 2008 to 2026, from 35 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (96 of 100 here), the regulation, and MAUDE report counts by product code.
System, Nuclear Magnetic Resonance Imaging. 21 CFR 892.1000, Class II. MAUDE held 4,787 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
- Siemens Medical Solutions USA, Inc.17
- Canon Medical Systems Corporation12
- Shanghai United Imaging Healthcare Co., Ltd.11
- Ge Medical Systems, LLC10
- Hyperfine, Inc.10
- GE Healthcare (Tianjin) Company Limited5
- Philips Medical Systems Nederland B.V.4
- Perspectum, Ltd.3
- Siemens Shenzhen Magnetic Resonance , Ltd.3
- Esaote, S.p.A.2
- Siemens Healthcare GmbH2
- FUJIFILM Healthcare Corporation2
- Resonance Health Analysis Services Pty Ltd2
- GE Medical Systems,LLC (GE Healthcare)2
- GE Healthcare (GE Medical Systems, LLC)2
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| uMR AstraK260113 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 withK253625 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| S-scan OpenK260746 · 510(k) | Esaote, S.p.A. | Radiology | database entry | |
| LiverMultiScanK253413 · 510(k) | Perspectum, Ltd. | Radiology | database entry | |
| Magnifico OpenK251901 · 510(k) | Esaote, S.p.A. | Radiology | database entry | |
| Ingenia, Ingenia CX, Ingenia Elition S/X, IngeniK253648 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | database entry | |
| MAGNETOM Flow.AceK260265 · 510(k) | Siemens Shenzhen Magnetic Resonance , Ltd. | Radiology | database entry | |
| SIGNA BoltK253780 · 510(k) | Ge Medical Systems, LLC | Radiology | database entry | |
| SIGNA Sprint SelectK253779 · 510(k) | Ge Medical Systems, LLC | Radiology | database entry | |
| AIR Recon DLK252379 · 510(k) | Ge Medical Systems, LLC | Radiology | database entry | |
| MAGNETOM SolaK252838 · 510(k) | Siemens Healthcare GmbH | Radiology | database entry | |
| Swoop Portable MR Imaging SystemK253489 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| MAGNETOM Free.MaxK251822 · 510(k) | Siemens Shenzhen Magnetic Resonance , Ltd. | Radiology | database entry | |
| uMR 680K252371 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| ECHELON SynergyK251386 · 510(k) | Fujifilm Corporation | Radiology | database entry | |
| SIGNA SprintK251399 · 510(k) | GE Medical Systems, LLC | Radiology | database entry | |
| MuscleView 2.0K251682 · 510(k) | Springbok, Inc. (dba Springbok Analytics) | Radiology | database entry | |
| Vista OS, Vista AI Scan, RTHawkK251029 · 510(k) | Vista AI, Inc. | Radiology | database entry | |
| uMR JupiterK250246 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 withK250901 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| uMR UltraK243547 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| uMR 680K243397 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| MAGNETOM Flow.AceK250436 · 510(k) | Siemens Shenzhen Magnetic Resonance , Ltd. | Radiology | database entry | |
| MAGNETOM Avanto FitK250443 · 510(k) | Siemens Healthcare GmbH | Radiology | database entry | |
| Sonic DLK243667 · 510(k) | GE Medical Systems, LLC | Radiology | database entry | |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia AmK251397 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | database entry | |
| Swoop Portable MR Imaging SystemK250236 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| uMR OmegaK243122 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| Swoop Portable MR Imaging SystemK251276 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| SIGNA Prime EliteK250379 · 510(k) | GE Medical Systems, LLC | Radiology | database entry | |
| Prenuvo Body CompositionK242825 · 510(k) | Prenuvo | Radiology | database entry | |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE RecoK243335 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| SIGNA MAGNUSK241242 · 510(k) | GE Medical Systems, LLC | Radiology | database entry | |
| MuscleViewK241331 · 510(k) | Springbok, Inc. | Radiology | database entry | |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE RecoK241496 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| ECHELON Synergy MRI SystemK241429 · 510(k) | FUJIFILM Healthcare Corporation | Radiology | database entry | |
| Swoop Portable MR Imaging SystemK240944 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| ECHELON Synergy V10.0K233687 · 510(k) | Fujifilm Healthcare Americas Corporation | Radiology | database entry | |
| uMR JupiterK233673 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd | Radiology | database entry | |
| Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 withK240238 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| uMR 680K240744 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| MAGNETOM TerraK232322 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| uMR OmegaK240540 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| MAGNETOM Cima.X FitK232765 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| SIGNA ChampionK233728 · 510(k) | GE Healthcare (Tianjin) Company Limited | Radiology | database entry | |
| MAGNETOM SolaK232535 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| MAGNETOM Cima.XK231587 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| MAGNETOM Avanto fitK232494 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| MAGNETOM Free.MaxK231617 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| MAGNETOM VidaK231560 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| Swoop Portable MR Imaging SystemK232760 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| MAGNETOM Viato.MobileK232482 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| Vantage Galan 3T, MRT-3020, V9.0 with AiCE ReconK230355 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| ECHELON Synergy MRI systemK223426 · 510(k) | FUJIFILM Healthcare Corporation | Radiology | database entry | |
| HepaFatSmartK231459 · 510(k) | Resonance Health Analysis Services Pty Ltd | Radiology | database entry | |
| Sonic DLK223523 · 510(k) | GE Medical Systems,LLC (GE Healthcare) | Radiology | database entry | |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia AmK223458 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | database entry | |
| MAGNETOM AmiraK223343 · 510(k) | Siemens Medical Solutions USA Inc. | Radiology | database entry | |
| Swoop Portable MR Imaging SystemK230208 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| uMR 680K222755 · 510(k) | Shanghai United Imaging Intelligence Co., Ltd. | Radiology | database entry | |
| SIGNA VictorK223439 · 510(k) | GE Healthcare (Tianjin) Company Limited | Radiology | database entry | |
| MR 5300 and MR 7700 R11 MR SystemsK223442 · 510(k) | Philips Medical Systems Nederlands B.V. | Radiology | database entry | |
| Swoop Portable MR Imaging SystemK223247 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| uMR Omega with uWS-MR-MRSK220332 · 510(k) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | database entry | |
| MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitK221733 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| LiverMultiScan v5K213960 · 510(k) | Perspectum | Radiology | database entry | |
| Swoop Portable MR Imaging SystemK221923 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| MAGNETOM Free.Max, MAGNETOM Free.StarK220575 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| Swoop Portable MR Imaging SystemK221393 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| AIR Recon DLK213717 · 510(k) | GE Medical Systems,LLC (GE Healthcare) | Radiology | database entry | |
| Achieva, Ingenia, Ingenia CX, Ingenia Elition anK213583 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | database entry | |
| MAGNETOM Skyra FitK220589 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| MAGNETOM Lumina and MAGNETOM Vida Fit with syngoK220939 · 510(k) | Siemens Medical Solutions USA Inc. | Radiology | database entry | |
| Vantage Galan 3T, MRT-3020, V8.0 with AiCE ReconK220192 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| MAGNETOM Avanto FitK220151 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| MAGNETOM Vida with syngo MR XA50AK213693 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| SIGNA Artist EvoK213603 · 510(k) | GE Healthcare(Tianjin) Company Limited | Radiology | database entry | |
| SIGNA HeroK213668 · 510(k) | GE Healthcare (GE Medical Systems, LLC) | Radiology | database entry | |
| SIGNA PrimeK211980 · 510(k) | GE Healthcare (Tianjin) Company Limited | Radiology | database entry | |
| Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE RK213305 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| Swoop Point-of-Care Magnetic Resonance ImagingK212456 · 510(k) | Hyperfine, Inc. | Radiology | database entry | |
| MAGNETOM Free.MaxK210611 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| SIGNA 7.0TK211118 · 510(k) | GE Medical Systems, LLC | Radiology | database entry | |
| MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MK203443 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE ReconK203323 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| Vantage Orian 1.5T, MRT-1550, V6.0K202767 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| Hepatica v1K203280 · 510(k) | Perspectum Ltd. | Radiology | database entry | |
| HepaFat-AIK201039 · 510(k) | Resonance Health Analysis Services Pty Ltd | Radiology | database entry | |
| SIGNA 7.0TK201615 · 510(k) | GE Medical Systems, LLC | Radiology | database entry | |
| LiverMultiScanK202170 · 510(k) | Perspectum LTD | Radiology | database entry | |
| SIGNA ArtistK202238 · 510(k) | GE Healthcare (Tianjin) Company Limited | Radiology | database entry | |
| Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE RecK193097 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| uMR 780K193176 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd | Radiology | database entry | |
| SIGNA PremierK193282 · 510(k) | GE Healthcare (GE Medical Systems, LLC) | Radiology | database entry | |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE ReconK192574 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| RTHawk, HeartVista Cardiac PackageK183274 · 510(k) | HeartVista, Inc. | Radiology | database entry | |
| LiverMultiScanK190017 · 510(k) | Perspectum Diagnostics Ltd | Radiology | database entry | |
| SIGNA PremierK183231 · 510(k) | GE Medical Systems, LLC | Radiology | database entry | |
| AMRA ProfilerK173749 · 510(k) | AMRA Medical AB | Radiology | database entry | |
| IB NEURO, VERSION 1.0K080762 · 510(k) | IMAGING BIOMETRICS, LLC | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.