| I-Genius (100019400) (K261331) | Esaote, S.p.A. | 2026-07-31 |
| MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure (K260852) | Siemens Healthineers AG | 2026-07-31 |
| uMR Astra (K260113) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 |
| APERTO Lucent MRI System (K253862) | Fujifilm Corporation | 2026-04-06 |
| S-scan Open (100001800) (K260746) | Esaote, S.p.A. | 2026-03-27 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K253625) | Canon Medical Systems Corporation | 2026-03-27 |
| nordicAudio (1.0) (K251937) | Nordicneurolab AS | 2026-03-20 |
| Embrace Neonatal MRI System (K254277) | Aspect Imaging, Ltd. | 2026-03-13 |
| LiverMultiScan (v6.0) (K253413) | Perspectum, Ltd. | 2026-03-09 |
| Magnifico Open (100009900) (K251901) | Esaote, S.p.A. | 2026-03-05 |
| MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K260265) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 |
| Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades (K253648) | Philips Medical Systems Nederland B.V. | 2026-02-23 |
| SIGNA™ Bolt (K253780) | Ge Medical Systems, LLC | 2026-02-06 |
| SIGNA™ Sprint Select (K253779) | Ge Medical Systems, LLC | 2026-02-05 |
| Ascent3T Neonatal Magnetic Resonance Imaging System (K253499) | Eyas Medical Imaging, Inc. | 2026-01-26 |
| AIR Recon DL (K252379) | Ge Medical Systems, LLC | 2025-12-23 |
| 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 (K252838) | Siemens Healthcare GmbH | 2025-12-19 |
| Swoop® Portable MR Imaging® System (K253489) | Hyperfine, Inc. | 2025-12-12 |
| MAGNETOM Free.Max; MAGNETOM Free.Star (K251822) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-11-20 |
| uMR 680 (K252371) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-25 |
| ECHELON Synergy (K251386) | Fujifilm Corporation | 2025-09-17 |
| SIGNA™ Sprint (K251399) | Ge Medical Systems, LLC | 2025-09-11 |
| MuscleView 2.0 (K251682) | Springbok, Inc. (Dba Springbok Analytics) | 2025-09-09 |
| Vista OS, Vista AI Scan, RTHawk (K251029) | Vista AI, Inc. | 2025-08-21 |
| InVision™ 3T Recharge Operating Suite (K252239) | Imris Imaging, Inc. | 2025-08-06 |
| uMR Jupiter (K250246) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-08-05 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K250901) | Canon Medical Systems Corporation | 2025-07-22 |
| uMR Ultra (K243547) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| uMR 680 (K243397) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-16 |
| 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 (K251808) | Philips Medical Systems Nederland B.V. | 2025-07-11 |
| MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K250436) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-06-16 |
| MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (K250443) | Siemens Healthcare GmbH | 2025-06-16 |
| Sonic DL (K243667) | Ge Medical Systems, LLC | 2025-06-05 |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (K251397) | Philips Medical Systems Nederland B.V. | 2025-06-04 |
| Swoop® Portable MR Imaging® System (V2) (K250236) | Hyperfine, Inc. | 2025-05-30 |
| uMR Omega (K243122) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-21 |
| Swoop® Portable MR Imaging® System (K251276) | Hyperfine, Inc. | 2025-05-21 |
| SIGNA Prime Elite (K250379) | Ge Medical Systems, LLC | 2025-03-17 |
| SureWave Elastography (Q7000225) (K242006) | Quality Electrodynamics, LLC | 2025-02-12 |
| Prenuvo Body Composition (K242825) | Prenuvo | 2025-01-17 |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K243335) | Canon Medical Systems Corporation | 2025-01-07 |
| NIDO Baby Magnetic Resonance Imaging System (K242573) | Jiangsu Lici Medical Device Co., Ltd. | 2024-12-23 |
| SyMRI (K242524) | Syntheticmr AB (Publ.) | 2024-12-06 |
| MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (K242258) | Asg Superconductors S.P.A. | 2024-11-26 |
| SIGNA MAGNUS (K241242) | Ge Medical Systems, LLC | 2024-10-17 |
| VitruvianScan (v1.0) (K241925) | Perspectum, Ltd. | 2024-10-02 |
| MuscleView (K241331) | Springbok, Inc. | 2024-10-01 |
| MyoStrain (6.0) (K241607) | Myocardial Solutions, Inc. | 2024-08-26 |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K241496) | Canon Medical Systems Corporation | 2024-08-20 |
| ECHELON Synergy MRI System (K241429) | Fujifilm Healthcare Corporation | 2024-08-13 |
| neo315 (K231133) | Neoscan Solution GmbH | 2024-07-22 |
| Swoop® Portable MR Imaging® System (K240944) | Hyperfine, Inc. | 2024-07-16 |
| Magnifico Open (100009900); Magnifico MSK ( 100009910) (K241133) | Esaote, S.p.A. | 2024-06-26 |
| APERTO Lucent MRI System (K233629) | FUJIFILM Healthcare Americas Corporation | 2024-05-10 |
| ECHELON Synergy V10.0 (K233687) | FUJIFILM Healthcare Americas Corporation | 2024-05-03 |
| uMR Jupiter (K233673) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-26 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR (K240238) | Canon Medical Systems Corporation | 2024-04-12 |
| OASIS MRI System (K240571) | Fujifilm Healthcare Corporation | 2024-04-12 |
| uMR 680 (K240744) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-10 |
| MAGNETOM Viato.Mobile (K240608) | Siemens Medical Solutions USA, Inc. | 2024-03-29 |
| SyMRI (K233733) | Syntheticmr AB (Publ.) | 2024-03-26 |
| MAGNETOM Terra; MAGNETOM Terra.X (K232322) | Siemens Medical Solutions USA, Inc. | 2024-03-22 |
| uMR Omega (K240540) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-03-22 |
| MAGNETOM Cima.X Fit (K232765) | Siemens Medical Solutions USA, Inc. | 2024-02-29 |
| InVision™ 1.5 Surgical Theatre (K240157) | Deerfield Imaging, Inc. | 2024-02-15 |
| neuro42 MRI System (K232644) | Neuro42, Inc. | 2024-02-08 |
| SIGNA Champion (K233728) | Ge Healthcare (Tianjin) Company Limited | 2024-01-19 |
| MAGNETOM Sola; MAGNETOM Altea (K232535) | Siemens Medical Solutions USA, Inc. | 2023-12-22 |
| MAGNETOM Cima.X (K231587) | Siemens Medical Solutions USA, Inc. | 2023-12-18 |
| fMRI Hardware System (K232680) | Nordicneurolab AS | 2023-12-13 |
| MAGNETOM Avanto fit; MAGNETOM Skyra fit (K232494) | Siemens Medical Solutions USA, Inc. | 2023-11-14 |
| MAGNETOM Free.Max; MAGNETOM Free.Star (K231617) | Siemens Medical Solutions USA, Inc. | 2023-11-09 |
| Digital Expert Access with Remote Scanning (K232346) | GE Healthcare | 2023-10-27 |
| MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit (K231560) | Siemens Medical Solutions USA, Inc. | 2023-10-23 |
| Synq Software Version 1.3 (K232981) | Synaptive Medical, Inc. | 2023-10-11 |
| Swoop® Portable MR Imaging System® (K232760) | Hyperfine, Inc. | 2023-10-06 |
| Terran NM-101 (K230187) | Terran Biosciences, Inc. | 2023-09-29 |
| MAGNETOM Viato.Mobile (K232482) | Siemens Medical Solutions USA, Inc. | 2023-09-06 |
| Promaxo MRI System II (K232361) | Promaxo, Inc. | 2023-09-05 |
| Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR (K230355) | Canon Medical Systems Corporation | 2023-08-30 |
| Ingenia Elition R5.7.1 SP4 MR Systems (K232030) | Philips Medical Systems Nederland B.V. | 2023-08-02 |
| ECHELON Synergy MRI system (K223426) | Fujifilm Healthcare Corporation | 2023-07-13 |
| HepaFatSmart (V2.0.0) (K231459) | Resonance Health Analysis Services Pty, Ltd. | 2023-06-20 |
| Sonic DL (K223523) | Ge Medical Systems,Llc (Ge Healthcare) | 2023-05-30 |
| uMR Omega (K230152) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-23 |
| uMR 570 (K230758) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-18 |
| Ingenia Elition and MR 7700 MR Systems (K230972) | Philips Medical Systems Nederland B.V. | 2023-04-28 |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems (K223458) | Philips Medical Systems Nederland B.V. | 2023-04-06 |
| MAGNETOM Amira; MAGNETOM Sempra (K223343) | Siemens Medical Solutions USA, Inc. | 2023-03-28 |
| MOBINEURO Alita Intraoperative MRI System (K223875) | Sino Canada Health Engineering Research Institute (Hefei) | 2023-03-20 |
| 1.5T 24E Posterior Array (K223203) | Shenzhen RF Tech Co., Ltd. | 2023-03-02 |
| MAGNETOM Vida (K213805) | Siemens Medical Solutions USA, Inc. | 2023-02-24 |
| Swoop® Portable MR Imaging System™ (K230208) | Hyperfine, Inc. | 2023-02-22 |
| NEONA 1.5T MRI System (K222259) | Time Medical Limited | 2023-02-21 |
| uMR 680 (K222755) | Shanghai United Imaging Intelligence Co., Ltd. | 2023-02-16 |
| SIGNA Victor (K223439) | Ge Healthcare (Tianjin) Company Limited | 2023-02-13 |
| ECHELON Oval V6.2 MRI System (K221619) | Fujifilm Healthcare Corporation | 2023-01-26 |
| MR 5300 and MR 7700 R11 MR Systems (K223442) | Philips Medical Systems Nederlands B.V. | 2022-12-23 |
| Swoop Portable MR Imaging System (K223247) | Hyperfine, Inc. | 2022-12-06 |
| Stage (K223079) | Spintech, Inc. | 2022-10-28 |