LNH
- 产品代码
- LNH
- 器械名称
- System, Nuclear Magnetic Resonance Imaging
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.1000
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 1104 件
该代码近三年的 510(k)（80 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K262622 | 2026-08-19 | Hyperfine, Inc. | Swoop® Portable MR Imaging® System 摘要 |
| K254250 | 2026-08-17 | Xingaoyi Medical Equipment Co.,Ltd | MagicScan-1.5, GreenMR Serenity 1.5T 摘要 |
| K253808 | 2026-08-13 | GE Medical Systems | AIR Recon DL 摘要 |
| K260852 | 2026-07-31 | Siemens Healthineers AG | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow. 摘要 |
| K261331 | 2026-07-31 | Esaote, S.p.A. | I-Genius (100019400) 摘要 |
| K260113 | 2026-05-22 | Shanghai United Imaging Healthcare Co. | uMR Astra 摘要 |
| K253862 | 2026-04-06 | Fujifilm Corporation | APERTO Lucent MRI System 摘要 |
| K260746 | 2026-03-27 | Esaote, S.p.A. | S-scan Open (100001800) 摘要 |
| K253625 | 2026-03-27 | Canon Medical Systems Corporation | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiC 摘要 |
| K251937 | 2026-03-20 | Nordicneurolab AS | nordicAudio (1.0) 摘要 |
| K254277 | 2026-03-13 | Aspect Imaging, Ltd. | Embrace Neonatal MRI System 摘要 |
| K253413 | 2026-03-09 | Perspectum, Ltd. | LiverMultiScan (v6.0) 摘要 |
| K251901 | 2026-03-05 | Esaote, S.p.A. | Magnifico Open (100009900) 摘要 |
| K253648 | 2026-02-23 | Philips Medical Systems Nederland B.V. | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Am 摘要 |
| K260265 | 2026-02-23 | Siemens Shenzhen Magnetic Resonance , | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus 摘要 |
| K253780 | 2026-02-06 | Ge Medical Systems, LLC | SIGNA Bolt 摘要 |
| K253779 | 2026-02-05 | Ge Medical Systems, LLC | SIGNA Sprint Select 摘要 |
| K253499 | 2026-01-26 | Eyas Medical Imaging, Inc. | Ascent3T Neonatal Magnetic Resonance Imaging System 摘要 |
| K252379 | 2025-12-23 | Ge Medical Systems, LLC | AIR Recon DL 摘要 |
| K252838 | 2025-12-19 | Siemens Healthcare GmbH | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MA 摘要 |
| K253489 | 2025-12-12 | Hyperfine, Inc. | Swoop® Portable MR Imaging® System 摘要 |
| K251822 | 2025-11-20 | Siemens Shenzhen Magnetic Resonance , | MAGNETOM Free.Max; MAGNETOM Free.Star 摘要 |
| K252371 | 2025-09-25 | Shanghai United Imaging Healthcare Co. | uMR 680 摘要 |
| K251386 | 2025-09-17 | Fujifilm Corporation | ECHELON Synergy 摘要 |
| K251399 | 2025-09-11 | Ge Medical Systems, LLC | SIGNA Sprint 摘要 |
| K251682 | 2025-09-09 | Springbok, Inc. (Dba Springbok Analyti | MuscleView 2.0 摘要 |
| K251029 | 2025-08-21 | Vista AI, Inc. | Vista OS, Vista AI Scan, RTHawk 摘要 |
| K252239 | 2025-08-06 | Imris Imaging, Inc. | InVision 3T Recharge Operating Suite 摘要 |
| K250246 | 2025-08-05 | Shanghai United Imaging Healthcare Co. | uMR Jupiter 摘要 |
| K250901 | 2025-07-22 | Canon Medical Systems Corporation | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiC 摘要 |
| K243547 | 2025-07-17 | Shanghai United Imaging Healthcare Co. | uMR Ultra 摘要 |
| K243397 | 2025-07-16 | Shanghai United Imaging Healthcare Co. | uMR 680 摘要 |
| K251808 | 2025-07-11 | Philips Medical Systems Nederland B.V. | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 摘要 |
| K250443 | 2025-06-16 | Siemens Healthcare GmbH | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM So 摘要 |
| K250436 | 2025-06-16 | Siemens Shenzhen Magnetic Resonance , | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus 摘要 |
| K243667 | 2025-06-05 | Ge Medical Systems, LLC | Sonic DL 摘要 |
| K251397 | 2025-06-04 | Philips Medical Systems Nederland B.V. | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambiti 摘要 |
| K250236 | 2025-05-30 | Hyperfine, Inc. | Swoop® Portable MR Imaging® System (V2) 摘要 |
| K251276 | 2025-05-21 | Hyperfine, Inc. | Swoop® Portable MR Imaging® System 摘要 |
| K243122 | 2025-05-21 | Shanghai United Imaging Healthcare Co. | uMR Omega 摘要 |
| K250379 | 2025-03-17 | Ge Medical Systems, LLC | SIGNA Prime Elite 摘要 |
| K242006 | 2025-02-12 | Quality Electrodynamics, LLC | SureWave Elastography (Q7000225) 摘要 |
| K242825 | 2025-01-17 | Prenuvo | Prenuvo Body Composition |
| K243335 | 2025-01-07 | Canon Medical Systems Corporation | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstr 摘要 |
| K242573 | 2024-12-23 | Jiangsu Lici Medical Device Co., Ltd. | NIDO Baby Magnetic Resonance Imaging System 摘要 |
| K242524 | 2024-12-06 | Syntheticmr AB (Publ.) | SyMRI 摘要 |
| K242258 | 2024-11-26 | Asg Superconductors S.P.A. | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) 摘要 |
| K241242 | 2024-10-17 | Ge Medical Systems, LLC | SIGNA MAGNUS 摘要 |
| K241925 | 2024-10-02 | Perspectum, Ltd. | VitruvianScan (v1.0) 摘要 |
| K241331 | 2024-10-01 | Springbok, Inc. | MuscleView 摘要 |
| K241607 | 2024-08-26 | Myocardial Solutions, Inc. | MyoStrain (6.0) 摘要 |
| K241496 | 2024-08-20 | Canon Medical Systems Corporation | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstr 摘要 |
| K241429 | 2024-08-13 | Fujifilm Healthcare Corporation | ECHELON Synergy MRI System 摘要 |
| K231133 | 2024-07-22 | Neoscan Solution GmbH | neo315 摘要 |
| K240944 | 2024-07-16 | Hyperfine, Inc. | Swoop® Portable MR Imaging® System 摘要 |
| K241133 | 2024-06-26 | Esaote, S.p.A. | Magnifico Open (100009900); Magnifico MSK ( 10000991 摘要 |
| K233629 | 2024-05-10 | FUJIFILM Healthcare Americas Corporati | APERTO Lucent MRI System 摘要 |
| K233687 | 2024-05-03 | FUJIFILM Healthcare Americas Corporati | ECHELON Synergy V10.0 摘要 |
| K233673 | 2024-04-26 | Shanghai United Imaging Healthcare Co. | uMR Jupiter 摘要 |
| K240238 | 2024-04-12 | Canon Medical Systems Corporation | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE 摘要 |
| K240571 | 2024-04-12 | Fujifilm Healthcare Corporation | OASIS MRI System 摘要 |
| K240744 | 2024-04-10 | Shanghai United Imaging Healthcare Co. | uMR 680 摘要 |
| K240608 | 2024-03-29 | Siemens Medical Solutions USA, Inc. | MAGNETOM Viato.Mobile 摘要 |
| K233733 | 2024-03-26 | Syntheticmr AB (Publ.) | SyMRI 摘要 |
| K240540 | 2024-03-22 | Shanghai United Imaging Healthcare Co. | uMR Omega 摘要 |
| K232322 | 2024-03-22 | Siemens Medical Solutions USA, Inc. | MAGNETOM Terra; MAGNETOM Terra.X 摘要 |
| K232765 | 2024-02-29 | Siemens Medical Solutions USA, Inc. | MAGNETOM Cima.X Fit 摘要 |
| K240157 | 2024-02-15 | Deerfield Imaging, Inc. | InVision 1.5 Surgical Theatre 摘要 |
| K232644 | 2024-02-08 | Neuro42, Inc. | neuro42 MRI System 摘要 |
| K233728 | 2024-01-19 | Ge Healthcare (Tianjin) Company Limite | SIGNA Champion 摘要 |
| K232535 | 2023-12-22 | Siemens Medical Solutions USA, Inc. | MAGNETOM Sola; MAGNETOM Altea 摘要 |
| K231587 | 2023-12-18 | Siemens Medical Solutions USA, Inc. | MAGNETOM Cima.X 摘要 |
| K232680 | 2023-12-13 | Nordicneurolab AS | fMRI Hardware System 摘要 |
| K232494 | 2023-11-14 | Siemens Medical Solutions USA, Inc. | MAGNETOM Avanto fit; MAGNETOM Skyra fit 摘要 |
| K231617 | 2023-11-09 | Siemens Medical Solutions USA, Inc. | MAGNETOM Free.Max; MAGNETOM Free.Star 摘要 |
| K232346 | 2023-10-27 | GE Healthcare | Digital Expert Access with Remote Scanning 摘要 |
| K231560 | 2023-10-23 | Siemens Medical Solutions USA, Inc. | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNE 摘要 |
| K232981 | 2023-10-11 | Synaptive Medical, Inc. | Synq Software Version 1.3 摘要 |
| K232760 | 2023-10-06 | Hyperfine, Inc. | Swoop® Portable MR Imaging System® 摘要 |
| K230187 | 2023-09-29 | Terran Biosciences, Inc. | Terran NM-101 摘要 |
FDA 官方分类页： LNH
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。