Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LNH · Predicate Candidate Screening
1,101 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
226 days90th percentile
1,101clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261331 | I-Genius (100019400) | Esaote, S.p.A. | 2026-07-31 | 100 | 0 |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAG | Siemens Healthineers AG | 2026-07-31 | 137 | 0 |
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 | 128 | 0 |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-04-06 | 124 | 0 |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026-03-27 | 21 | 0 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Recons | Canon Medical Systems Corporation | 2026-03-27 | 129 | 0 |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026-03-20 | 269 | 0 |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026-03-13 | 73 | 0 |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026-03-09 | 159 | 0 |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | 2026-03-05 | 258 | 0 |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 | 26 | 0 |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S | Philips Medical Systems Nederland B.V. | 2026-02-23 | 95 | 0 |
| K253780 | SIGNA™ Bolt | Ge Medical Systems, LLC | 2026-02-06 | 72 | 0 |
| K253779 | SIGNA™ Sprint Select | Ge Medical Systems, LLC | 2026-02-05 | 71 | 0 |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | 2026-01-26 | 89 | 0 |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 2025-12-23 | 146 | 0 |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM V | Siemens Healthcare GmbH | 2025-12-19 | 105 | 0 |
| K253489 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025-12-12 | 49 | 0 |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-11-20 | 160 | 0 |
| K252371 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-25 | 57 | 0 |
| K251386 | ECHELON Synergy | Fujifilm Corporation | 2025-09-17 | 135 | 0 |
| K251399 | SIGNA™ Sprint | Ge Medical Systems, LLC | 2025-09-11 | 128 | 0 |
| K251682 | MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) | 2025-09-09 | 102 | 0 |
| K251029 | Vista OS, Vista AI Scan, RTHawk | Vista AI, Inc. | 2025-08-21 | 141 | 0 |
| K252239 | InVision™ 3T Recharge Operating Suite | Imris Imaging, Inc. | 2025-08-06 | 20 | 0 |
| K250246 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | 2025-08-05 | 190 | 0 |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Recons | Canon Medical Systems Corporation | 2025-07-22 | 118 | 0 |
| K243547 | uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 | 244 | 0 |
| K243397 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-16 | 258 | 0 |
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX | Philips Medical Systems Nederland B.V. | 2025-07-11 | 29 | 7 |
| K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-06-16 | 122 | 0 |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; | Siemens Healthcare GmbH | 2025-06-16 | 122 | 2 |
| K243667 | Sonic DL | Ge Medical Systems, LLC | 2025-06-05 | 190 | 0 |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, Blue | Philips Medical Systems Nederland B.V. | 2025-06-04 | 29 | 8 |
| K250236 | Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc. | 2025-05-30 | 123 | 0 |
| K243122 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-21 | 233 | 0 |
| K251276 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025-05-21 | 27 | 0 |
| K250379 | SIGNA Prime Elite | Ge Medical Systems, LLC | 2025-03-17 | 34 | 0 |
| K242006 | SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC | 2025-02-12 | 218 | 0 |
| K242825 | Prenuvo Body Composition | Prenuvo | 2025-01-17 | 121 | 0 |
| K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction P | Canon Medical Systems Corporation | 2025-01-07 | 75 | 1 |
| K242573 | NIDO Baby Magnetic Resonance Imaging System | Jiangsu Lici Medical Device Co., Ltd. | 2024-12-23 | 116 | 0 |
| K242524 | SyMRI | Syntheticmr AB (Publ.) | 2024-12-06 | 105 | 0 |
| K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | Asg Superconductors S.P.A. | 2024-11-26 | 118 | 0 |
| K241242 | SIGNA MAGNUS | Ge Medical Systems, LLC | 2024-10-17 | 167 | 0 |
| K241925 | VitruvianScan (v1.0) | Perspectum, Ltd. | 2024-10-02 | 93 | 0 |
| K241331 | MuscleView | Springbok, Inc. | 2024-10-01 | 144 | 0 |
| K241607 | MyoStrain (6.0) | Myocardial Solutions, Inc. | 2024-08-26 | 83 | 0 |
| K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction P | Canon Medical Systems Corporation | 2024-08-20 | 84 | 0 |
| K241429 | ECHELON Synergy MRI System | Fujifilm Healthcare Corporation | 2024-08-13 | 84 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda