甘先生 · haixiao@sungolytest.com · 158 2169 5110 微信 · 132 4819 8029罗先生 · jun.luo@sungoglobal.com · 177 5560 4650 微信

LNH

System, Nuclear Magnetic Resonance Imaging

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)
80 件
其中 Summary 已存档
71 份,可直接下载
FDA 历史累计 510(k)
1104 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(80 件)

数据窗口为最近三年。最新一件:2026-08-19。

510(k) 号批准日期申请人器械名称摘要
K2626222026-08-19Hyperfine, Inc.Swoop® Portable MR Imaging® SystemPDF
K2542502026-08-17Xingaoyi Medical Equipment Co.,LtdMagicScan-1.5, GreenMR Serenity 1.5TPDF
K2538082026-08-13GE Medical SystemsAIR Recon DLPDF
K2608522026-07-31Siemens Healthineers AGMAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.…PDF
K2613312026-07-31Esaote, S.p.A.I-Genius (100019400)FDA
K2601132026-05-22Shanghai United Imaging Healthcare Co.…uMR AstraPDF
K2538622026-04-06Fujifilm CorporationAPERTO Lucent MRI SystemPDF
K2607462026-03-27Esaote, S.p.A.S-scan Open (100001800)PDF
K2536252026-03-27Canon Medical Systems CorporationVantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiC…PDF
K2519372026-03-20Nordicneurolab ASnordicAudio (1.0)PDF
K2542772026-03-13Aspect Imaging, Ltd.Embrace Neonatal MRI SystemPDF
K2534132026-03-09Perspectum, Ltd.LiverMultiScan (v6.0)PDF
K2519012026-03-05Esaote, S.p.A.Magnifico Open (100009900)PDF
K2536482026-02-23Philips Medical Systems Nederland B.V.Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Am…PDF
K2602652026-02-23Siemens Shenzhen Magnetic Resonance , …MAGNETOM Flow.Ace; MAGNETOM Flow.PlusPDF
K2537802026-02-06Ge Medical Systems, LLCSIGNA™ BoltPDF
K2537792026-02-05Ge Medical Systems, LLCSIGNA™ Sprint SelectPDF
K2534992026-01-26Eyas Medical Imaging, Inc.Ascent3T Neonatal Magnetic Resonance Imaging SystemFDA
K2523792025-12-23Ge Medical Systems, LLCAIR Recon DLPDF
K2528382025-12-19Siemens Healthcare GmbHMAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MA…FDA
K2534892025-12-12Hyperfine, Inc.Swoop® Portable MR Imaging® SystemPDF
K2518222025-11-20Siemens Shenzhen Magnetic Resonance , …MAGNETOM Free.Max; MAGNETOM Free.StarPDF
K2523712025-09-25Shanghai United Imaging Healthcare Co.…uMR 680PDF
K2513862025-09-17Fujifilm CorporationECHELON SynergyPDF
K2513992025-09-11Ge Medical Systems, LLCSIGNA™ SprintPDF
K2516822025-09-09Springbok, Inc. (Dba Springbok Analyti…MuscleView 2.0FDA
K2510292025-08-21Vista AI, Inc.Vista OS, Vista AI Scan, RTHawkPDF
K2522392025-08-06Imris Imaging, Inc.InVision™ 3T Recharge Operating SuitePDF
K2502462025-08-05Shanghai United Imaging Healthcare Co.…uMR JupiterPDF
K2509012025-07-22Canon Medical Systems CorporationVantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiC…FDA
K2435472025-07-17Shanghai United Imaging Healthcare Co.…uMR UltraPDF
K2433972025-07-16Shanghai United Imaging Healthcare Co.…uMR 680PDF
K2518082025-07-11Philips Medical Systems Nederland B.V.Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia…PDF
K2504432025-06-16Siemens Healthcare GmbHMAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM So…PDF
K2504362025-06-16Siemens Shenzhen Magnetic Resonance , …MAGNETOM Flow.Ace; MAGNETOM Flow.PlusPDF
K2436672025-06-05Ge Medical Systems, LLCSonic DLPDF
K2513972025-06-04Philips Medical Systems Nederland B.V.Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambiti…PDF
K2502362025-05-30Hyperfine, Inc.Swoop® Portable MR Imaging® System (V2)PDF
K2512762025-05-21Hyperfine, Inc.Swoop® Portable MR Imaging® SystemPDF
K2431222025-05-21Shanghai United Imaging Healthcare Co.…uMR OmegaPDF
K2503792025-03-17Ge Medical Systems, LLCSIGNA Prime ElitePDF
K2420062025-02-12Quality Electrodynamics, LLCSureWave Elastography (Q7000225)PDF
K2428252025-01-17PrenuvoPrenuvo Body Composition—
K2433352025-01-07Canon Medical Systems CorporationVantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstr…PDF
K2425732024-12-23Jiangsu Lici Medical Device Co., Ltd.NIDO Baby Magnetic Resonance Imaging SystemPDF
K2425242024-12-06Syntheticmr AB (Publ.)SyMRIPDF
K2422582024-11-26Asg Superconductors S.P.A.MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)PDF
K2412422024-10-17Ge Medical Systems, LLCSIGNA MAGNUSPDF
K2419252024-10-02Perspectum, Ltd.VitruvianScan (v1.0)FDA
K2413312024-10-01Springbok, Inc.MuscleViewPDF
K2416072024-08-26Myocardial Solutions, Inc.MyoStrain (6.0)PDF
K2414962024-08-20Canon Medical Systems CorporationVantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstr…PDF
K2414292024-08-13Fujifilm Healthcare CorporationECHELON Synergy MRI SystemPDF
K2311332024-07-22Neoscan Solution GmbHneo315PDF
K2409442024-07-16Hyperfine, Inc.Swoop® Portable MR Imaging® SystemPDF
K2411332024-06-26Esaote, S.p.A.Magnifico Open (100009900); Magnifico MSK ( 10000991…FDA
K2336292024-05-10FUJIFILM Healthcare Americas Corporati…APERTO Lucent MRI SystemPDF
K2336872024-05-03FUJIFILM Healthcare Americas Corporati…ECHELON Synergy V10.0PDF
K2336732024-04-26Shanghai United Imaging Healthcare Co.…uMR JupiterFDA
K2402382024-04-12Canon Medical Systems CorporationVantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE…PDF
K2405712024-04-12Fujifilm Healthcare CorporationOASIS MRI SystemPDF
K2407442024-04-10Shanghai United Imaging Healthcare Co.…uMR 680PDF
K2406082024-03-29Siemens Medical Solutions USA, Inc.MAGNETOM Viato.MobilePDF
K2337332024-03-26Syntheticmr AB (Publ.)SyMRIPDF
K2405402024-03-22Shanghai United Imaging Healthcare Co.…uMR OmegaPDF
K2323222024-03-22Siemens Medical Solutions USA, Inc.MAGNETOM Terra; MAGNETOM Terra.XPDF
K2327652024-02-29Siemens Medical Solutions USA, Inc.MAGNETOM Cima.X FitPDF
K2401572024-02-15Deerfield Imaging, Inc.InVision™ 1.5 Surgical TheatrePDF
K2326442024-02-08Neuro42, Inc.neuro42 MRI SystemPDF
K2337282024-01-19Ge Healthcare (Tianjin) Company Limite…SIGNA ChampionPDF
K2325352023-12-22Siemens Medical Solutions USA, Inc.MAGNETOM Sola; MAGNETOM AlteaPDF
K2315872023-12-18Siemens Medical Solutions USA, Inc.MAGNETOM Cima.XPDF
K2326802023-12-13Nordicneurolab ASfMRI Hardware SystemPDF
K2324942023-11-14Siemens Medical Solutions USA, Inc.MAGNETOM Avanto fit; MAGNETOM Skyra fitPDF
K2316172023-11-09Siemens Medical Solutions USA, Inc.MAGNETOM Free.Max; MAGNETOM Free.StarPDF
K2323462023-10-27GE HealthcareDigital Expert Access with Remote ScanningPDF
K2315602023-10-23Siemens Medical Solutions USA, Inc.MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNE…PDF
K2329812023-10-11Synaptive Medical, Inc.Synq Software Version 1.3PDF
K2327602023-10-06Hyperfine, Inc.Swoop® Portable MR Imaging System®PDF
K2301872023-09-29Terran Biosciences, Inc.Terran NM-101PDF

其中 71 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。