FDA Product Code
FDA Product Code LNH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1000
510(k) Clearances — 1,108 records · page 1 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261612 | SwiftSight-BodyComposition | Airs Medical, Inc. | 2026-10-01 | Traditional | PDF ↗ |
| K261758 | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | 2026-09-16 | Traditional | PDF ↗ |
| K261283 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-09-16 | Traditional | PDF ↗ |
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-09-01 | Traditional | PDF ↗ |
| K262622 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2026-08-19 | Special | PDF ↗ |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co.,Ltd | 2026-08-17 | Traditional | PDF ↗ |
| K253808 | AIR Recon DL | GE Medical Systems | 2026-08-13 | Traditional | PDF ↗ |
| K261331 | I-Genius (100019400) | Esaote, S.p.A. | 2026-07-31 | Traditional | PDF ↗ |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | 2026-07-31 | Traditional | PDF ↗ |
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 | Traditional | PDF ↗ |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-04-06 | Traditional | PDF ↗ |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026-03-27 | Special | PDF ↗ |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2026-03-27 | Traditional | PDF ↗ |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026-03-20 | Traditional | PDF ↗ |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026-03-13 | Traditional | PDF ↗ |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026-03-09 | Traditional | PDF ↗ |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | 2026-03-05 | Traditional | PDF ↗ |
| 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. | 2026-02-23 | Abbreviated | PDF ↗ |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 | Special | PDF ↗ |
| K253780 | SIGNA Bolt | Ge Medical Systems, LLC | 2026-02-06 | Traditional | PDF ↗ |
| K253779 | SIGNA Sprint Select | Ge Medical Systems, LLC | 2026-02-05 | Traditional | PDF ↗ |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | 2026-01-26 | Traditional | PDF ↗ |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 2025-12-23 | Traditional | PDF ↗ |
| 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 | 2025-12-19 | Traditional | PDF ↗ |
| K253489 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025-12-12 | Special | PDF ↗ |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-11-20 | Traditional | PDF ↗ |
| K252371 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-25 | Special | PDF ↗ |
| K251386 | ECHELON Synergy | Fujifilm Corporation | 2025-09-17 | Traditional | PDF ↗ |
| K251399 | SIGNA Sprint | Ge Medical Systems, LLC | 2025-09-11 | Traditional | PDF ↗ |
| K251682 | MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) | 2025-09-09 | Traditional | PDF ↗ |
| K251029 | Vista OS, Vista AI Scan, RTHawk | Vista AI, Inc. | 2025-08-21 | Traditional | PDF ↗ |
| K252239 | InVision 3T Recharge Operating Suite | Imris Imaging, Inc. | 2025-08-06 | Traditional | PDF ↗ |
| K250246 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | 2025-08-05 | Traditional | PDF ↗ |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2025-07-22 | Traditional | PDF ↗ |
| K243547 | uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 | Traditional | PDF ↗ |
| K243397 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-16 | Traditional | PDF ↗ |
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems | Philips Medical Systems Nederland B.V. | 2025-07-11 | Special | PDF ↗ |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | Siemens Healthcare GmbH | 2025-06-16 | Traditional | PDF ↗ |
| K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-06-16 | Traditional | PDF ↗ |
| K243667 | Sonic DL | Ge Medical Systems, LLC | 2025-06-05 | Traditional | PDF ↗ |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | Philips Medical Systems Nederland B.V. | 2025-06-04 | Special | PDF ↗ |
| K250236 | Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc. | 2025-05-30 | Traditional | PDF ↗ |
| K243122 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-21 | Traditional | PDF ↗ |
| K251276 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025-05-21 | Special | PDF ↗ |
| K250379 | SIGNA Prime Elite | Ge Medical Systems, LLC | 2025-03-17 | Traditional | PDF ↗ |
| K242006 | SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC | 2025-02-12 | Traditional | PDF ↗ |
| K242825 | Prenuvo Body Composition | Prenuvo | 2025-01-17 | Traditional | PDF ↗ |
| K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2025-01-07 | Traditional | PDF ↗ |
| K242573 | NIDO Baby Magnetic Resonance Imaging System | Jiangsu Lici Medical Device Co., Ltd. | 2024-12-23 | Traditional | PDF ↗ |
| K242524 | SyMRI | Syntheticmr AB (Publ.) | 2024-12-06 | Traditional | PDF ↗ |
| K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | Asg Superconductors S.P.A. | 2024-11-26 | Traditional | PDF ↗ |
| K241242 | SIGNA MAGNUS | Ge Medical Systems, LLC | 2024-10-17 | Traditional | PDF ↗ |
| K241925 | VitruvianScan (v1.0) | Perspectum, Ltd. | 2024-10-02 | Traditional | PDF ↗ |
| K241331 | MuscleView | Springbok, Inc. | 2024-10-01 | Traditional | PDF ↗ |
| K241607 | MyoStrain (6.0) | Myocardial Solutions, Inc. | 2024-08-26 | Special | PDF ↗ |
| K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2024-08-20 | Traditional | PDF ↗ |
| K241429 | ECHELON Synergy MRI System | Fujifilm Healthcare Corporation | 2024-08-13 | Traditional | PDF ↗ |
| K231133 | neo315 | Neoscan Solution GmbH | 2024-07-22 | Traditional | PDF ↗ |
| K240944 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2024-07-16 | Special | PDF ↗ |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | Esaote, S.p.A. | 2024-06-26 | Special | PDF ↗ |
| K233629 | APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation | 2024-05-10 | Traditional | PDF ↗ |
| K233687 | ECHELON Synergy V10.0 | FUJIFILM Healthcare Americas Corporation | 2024-05-03 | Traditional | PDF ↗ |
| K233673 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-26 | Traditional | PDF ↗ |
| K240571 | OASIS MRI System | Fujifilm Healthcare Corporation | 2024-04-12 | Traditional | PDF ↗ |
| K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2024-04-12 | Traditional | PDF ↗ |
| K240744 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-10 | Special | PDF ↗ |
| K240608 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | 2024-03-29 | Special | PDF ↗ |
| K233733 | SyMRI | Syntheticmr AB (Publ.) | 2024-03-26 | Traditional | PDF ↗ |
| K240540 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2024-03-22 | Special | PDF ↗ |
| K232322 | MAGNETOM Terra; MAGNETOM Terra.X | Siemens Medical Solutions USA, Inc. | 2024-03-22 | Traditional | PDF ↗ |
| K232765 | MAGNETOM Cima.X Fit | Siemens Medical Solutions USA, Inc. | 2024-02-29 | Traditional | PDF ↗ |
| K240157 | InVision 1.5 Surgical Theatre | Deerfield Imaging, Inc. | 2024-02-15 | Traditional | PDF ↗ |
| K232644 | neuro42 MRI System | Neuro42, Inc. | 2024-02-08 | Traditional | PDF ↗ |
| K233728 | SIGNA Champion | Ge Healthcare (Tianjin) Company Limited | 2024-01-19 | Traditional | PDF ↗ |
| K232535 | MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | 2023-12-22 | Traditional | PDF ↗ |
| K231587 | MAGNETOM Cima.X | Siemens Medical Solutions USA, Inc. | 2023-12-18 | Traditional | PDF ↗ |
| K232680 | fMRI Hardware System | Nordicneurolab AS | 2023-12-13 | Traditional | PDF ↗ |
| K232494 | MAGNETOM Avanto fit; MAGNETOM Skyra fit | Siemens Medical Solutions USA, Inc. | 2023-11-14 | Traditional | PDF ↗ |
| K231617 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | 2023-11-09 | Traditional | PDF ↗ |
| K232346 | Digital Expert Access with Remote Scanning | GE Healthcare | 2023-10-27 | Traditional | PDF ↗ |
| K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | Siemens Medical Solutions USA, Inc. | 2023-10-23 | Traditional | PDF ↗ |
| K232981 | Synq Software Version 1.3 | Synaptive Medical, Inc. | 2023-10-11 | Traditional | PDF ↗ |
| K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | 2023-10-06 | Special | PDF ↗ |
| K230187 | Terran NM-101 | Terran Biosciences, Inc. | 2023-09-29 | Traditional | PDF ↗ |
| K232482 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | 2023-09-06 | Special | PDF ↗ |
| K232361 | Promaxo MRI System II | Promaxo, Inc. | 2023-09-05 | Special | PDF ↗ |
| K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2023-08-30 | Traditional | PDF ↗ |
| K232030 | Ingenia Elition R5.7.1 SP4 MR Systems | Philips Medical Systems Nederland B.V. | 2023-08-02 | Special | PDF ↗ |
| K223426 | ECHELON Synergy MRI system | Fujifilm Healthcare Corporation | 2023-07-13 | Traditional | PDF ↗ |
| K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty, Ltd. | 2023-06-20 | Special | PDF ↗ |
| K223523 | Sonic DL | Ge Medical Systems,Llc (Ge Healthcare) | 2023-05-30 | Traditional | PDF ↗ |
| K230152 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-23 | Traditional | PDF ↗ |
| K230758 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-18 | Traditional | PDF ↗ |
| K230972 | Ingenia Elition and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | 2023-04-28 | Special | PDF ↗ |
| K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | 2023-04-06 | Abbreviated | PDF ↗ |
| K223343 | MAGNETOM Amira; MAGNETOM Sempra | Siemens Medical Solutions USA, Inc. | 2023-03-28 | Traditional | PDF ↗ |
| K223875 | MOBINEURO Alita Intraoperative MRI System | Sino Canada Health Engineering Research Institute (Hefei) | 2023-03-20 | Traditional | PDF ↗ |
| K223203 | 1.5T 24E Posterior Array | Shenzhen RF Tech Co., Ltd. | 2023-03-02 | Traditional | PDF ↗ |
| K213805 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | 2023-02-24 | Traditional | PDF ↗ |
| K230208 | Swoop® Portable MR Imaging System | Hyperfine, Inc. | 2023-02-22 | Special | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.