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 2 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222259 | NEONA 1.5T MRI System | Time Medical Limited | 2023-02-21 | Abbreviated | PDF ↗ |
| K222755 | uMR 680 | Shanghai United Imaging Intelligence Co., Ltd. | 2023-02-16 | Traditional | PDF ↗ |
| K223439 | SIGNA Victor | Ge Healthcare (Tianjin) Company Limited | 2023-02-13 | Traditional | PDF ↗ |
| K221619 | ECHELON Oval V6.2 MRI System | Fujifilm Healthcare Corporation | 2023-01-26 | Traditional | PDF ↗ |
| K223442 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems Nederlands B.V. | 2022-12-23 | Special | PDF ↗ |
| K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022-12-06 | Special | PDF ↗ |
| K223079 | Stage | Spintech, Inc. | 2022-10-28 | Special | PDF ↗ |
| K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co., Ltd. | 2022-10-27 | Traditional | PDF ↗ |
| K222968 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2022-10-25 | Special | PDF ↗ |
| K221733 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit | Siemens Medical Solutions USA, Inc. | 2022-09-13 | Traditional | PDF ↗ |
| K213960 | LiverMultiScan v5 (LMSv5) | Perspectum | 2022-09-06 | Traditional | PDF ↗ |
| K222387 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2022-08-31 | Special | PDF ↗ |
| K221785 | TCL3 Motion Tracking System | Tracinnovations A/S | 2022-08-29 | Traditional | PDF ↗ |
| K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022-07-28 | Special | PDF ↗ |
| K203279 | Veuron-Brain-mN1 | Heuron Co., Ltd. | 2022-07-12 | Traditional | PDF ↗ |
| K221025 | i_ Field 1.5T Superconducting Magnetic Resonance Imaging System | Mri Division,Beijing Wandong Medical Technology Co., Ltd. | 2022-07-01 | Traditional | PDF ↗ |
| K220575 | MAGNETOM Free.Max, MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | 2022-06-24 | Traditional | PDF ↗ |
| K221393 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022-06-10 | Special | PDF ↗ |
| K213717 | AIR Recon DL | Ge Medical Systems,Llc (Ge Healthcare) | 2022-06-08 | Traditional | PDF ↗ |
| K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | 2022-05-16 | Abbreviated | PDF ↗ |
| K220589 | MAGNETOM Skyra Fit | Siemens Medical Solutions USA, Inc. | 2022-05-13 | Traditional | PDF ↗ |
| K220939 | MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A | Siemens Medical Solutions USA, Inc. | 2022-04-29 | Special | PDF ↗ |
| K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2022-04-08 | Traditional | PDF ↗ |
| K220335 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2022-04-05 | Traditional | PDF ↗ |
| K220151 | MAGNETOM Avanto Fit | Siemens Medical Solutions USA, Inc. | 2022-04-01 | Traditional | PDF ↗ |
| K220425 | MAGNETOM Vida, MAGNETOM Sola | Siemens Medical Solutions USA, Inc. | 2022-03-11 | Traditional | PDF ↗ |
| K220018 | MR Elastography; MZEK-001A | Canon Medical Systems Corporation | 2022-03-03 | Traditional | PDF ↗ |
| K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei | Philips Medical Systems Nederland B.V. | 2022-03-03 | Abbreviated | PDF ↗ |
| K213693 | MAGNETOM Vida with syngo MR XA50A | Siemens Medical Solutions USA, Inc. | 2022-02-25 | Traditional | PDF ↗ |
| K213603 | SIGNA Artist Evo | Ge Healthcare (Tianjin) Company Limited | 2022-02-11 | Traditional | PDF ↗ |
| K212271 | smart-sync | Northh Medical GmbH | 2022-02-04 | Traditional | PDF ↗ |
| K212419 | Magnifico Open, Magnifico MSK | Esaote, S.p.A. | 2022-02-04 | Traditional | PDF ↗ |
| K213668 | SIGNA Hero | Ge Healthcare (Ge Medical Systems, LLC) | 2022-01-20 | Traditional | PDF ↗ |
| K211980 | SIGNA Prime | Ge Healthcare (Tianjin) Company Limited | 2022-01-16 | Traditional | PDF ↗ |
| K213305 | Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021-12-01 | Traditional | PDF ↗ |
| K211983 | AMRA Profiler | Amra Medical AB | 2021-11-24 | Traditional | PDF ↗ |
| K212673 | MR 5300 | Philips Medical Systems Nederland B.V. | 2021-11-19 | Abbreviated | PDF ↗ |
| K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. | 2021-11-17 | Traditional | PDF ↗ |
| K203372 | SyMRI | Syntheticmr AB | 2021-11-03 | Traditional | PDF ↗ |
| K211406 | OASIS MRI System | Hitachi Healthcare Americas | 2021-10-07 | Traditional | PDF ↗ |
| K212233 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2021-10-05 | Traditional | PDF ↗ |
| K212367 | IMRIS iMRI 3T V | Deerfield Imaging, Inc. | 2021-08-23 | Traditional | PDF ↗ |
| K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021-08-04 | Traditional | PDF ↗ |
| K210415 | QSM software, QSMetric | Medimagemetric, LLC | 2021-07-22 | Traditional | PDF ↗ |
| K211633 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021-07-22 | Traditional | PDF ↗ |
| K211818 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. | 2021-07-07 | Special | PDF ↗ |
| K210611 | MAGNETOM Free.Max | Siemens Medical Solutions USA, Inc. | 2021-07-01 | Traditional | PDF ↗ |
| K210843 | STAGE | Spintech, Inc. | 2021-06-29 | Traditional | PDF ↗ |
| K211037 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021-05-17 | Traditional | PDF ↗ |
| K211118 | SIGNA 7.0T | Ge Medical Systems, LLC | 2021-05-13 | Special | PDF ↗ |
| K203451 | TCL3 Motion Tracking System | Tracinnovations Aps | 2021-04-28 | Traditional | PDF ↗ |
| K210340 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021-04-01 | Traditional | PDF ↗ |
| K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | 2021-03-31 | Traditional | PDF ↗ |
| K210164 | Vantage Elan 1.5T, MRT-2020, V6.0 | Canon Medical Systems Corporation | 2021-03-10 | Traditional | PDF ↗ |
| K203323 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021-03-04 | Traditional | PDF ↗ |
| K202518 | Promaxo MRI System | Promaxo, Inc. | 2021-03-03 | Traditional | PDF ↗ |
| K203653 | MRI PPG Patient Cable | Ivy Biomedical Systems, Inc. | 2021-03-02 | Traditional | PDF ↗ |
| K203553 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021-02-02 | Traditional | PDF ↗ |
| K192650 | i_Space 1.5T Superconducting Magnetic Resonance Imaging System | Mri Division,Beijing Wandong Medical Technology Co., Ltd. | 2021-01-29 | Traditional | PDF ↗ |
| K202767 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | 2021-01-15 | Traditional | PDF ↗ |
| K203280 | Hepatica v1 (Hepatica v1.0.0) | Perspectum, Ltd. | 2021-01-12 | Traditional | PDF ↗ |
| K201039 | HepaFat-AI | Resonance Health Analysis Services Pty, Ltd. | 2020-12-07 | Traditional | PDF ↗ |
| K203053 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2020-12-02 | Traditional | PDF ↗ |
| K202966 | SIGNA Architect | Ge Healthcare (Ge Medical Systems, LLC) | 2020-11-13 | Traditional | PDF ↗ |
| K202030 | OASIS MRI System | Hitachi Healthcare Americas | 2020-10-21 | Traditional | PDF ↗ |
| K201615 | SIGNA 7.0T | Ge Medical Systems, LLC | 2020-10-15 | Traditional | PDF ↗ |
| K202170 | LiverMultiScan | Perspectum, Ltd. | 2020-10-02 | Traditional | PDF ↗ |
| K202210 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | 2020-09-22 | Special | PDF ↗ |
| K202014 | Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit | Siemens Medical Solutions USA, Inc. | 2020-09-08 | Traditional | PDF ↗ |
| K202238 | SIGNA Artist | Ge Healthcare (Tianjin) Company Limited | 2020-09-04 | Special | PDF ↗ |
| K201141 | FIRMM | Nous Imaging, Inc. | 2020-08-26 | Traditional | PDF ↗ |
| K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine Research, Inc. | 2020-08-11 | Traditional | PDF ↗ |
| K201616 | SyMRI | Syntheticmr AB | 2020-07-28 | Traditional | PDF ↗ |
| K193097 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2020-07-14 | Traditional | PDF ↗ |
| K201389 | Resoundant Acoustic Driver System | Resoundant, Inc. | 2020-07-10 | Traditional | PDF ↗ |
| K201540 | uMR570 | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-06 | Special | PDF ↗ |
| K193021 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | 2020-06-03 | Traditional | PDF ↗ |
| K193176 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2020-05-05 | Traditional | PDF ↗ |
| K200327 | Evry | Synaptive Medical, Inc. | 2020-04-29 | Traditional | PDF ↗ |
| K200024 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | 2020-04-20 | Traditional | PDF ↗ |
| K193282 | SIGNA Premier | Ge Healthcare (Ge Medical Systems, LLC) | 2020-04-10 | Traditional | PDF ↗ |
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | 2020-04-10 | Abbreviated | PDF ↗ |
| K193218 | Innovision Audio | Innovere Medical, Inc. | 2020-04-07 | Traditional | PDF ↗ |
| K192852 | MRI ECG Patient Cable | Ivy Biomedical Systems, Inc. | 2020-03-28 | Traditional | PDF ↗ |
| K193200 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2020-03-27 | Traditional | PDF ↗ |
| K192924 | MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit | Siemens Medical Solutions USA, Inc. | 2020-03-11 | Traditional | PDF ↗ |
| K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2020-03-09 | Traditional | PDF ↗ |
| K192506 | Vantage Galan 3T, MRT-3020, V6.0 | Canon Medical Systems Corporation | 2020-03-02 | Traditional | PDF ↗ |
| K192496 | Magnetom Sola, Magnetom Altea and Magnetom Sola Fit | Siemens Medical Solutions USA, Inc. | 2020-02-28 | Traditional | PDF ↗ |
| K192851 | OASIS MRI System | Hitachi Healthcare Americas | 2020-02-21 | Traditional | PDF ↗ |
| K192002 | Lucy Point-of-Care Magnetic Resonance Imaging Device | Hyperfine Research, Inc. | 2020-02-06 | Traditional | PDF ↗ |
| K193324 | Motion Correction System | Kineticor, Inc. | 2020-02-04 | Traditional | PDF ↗ |
| K193102 | MRIaudio PREM System with MRIview | Mriaudio, Inc. | 2020-01-06 | Traditional | PDF ↗ |
| K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019-12-20 | Special | PDF ↗ |
| K191032 | fMRI Hardware System | Nordicneurolab AS | 2019-11-27 | Traditional | PDF ↗ |
| K192690 | Upgrade Kit MR GUI PRO, MrJ 3300 Plus | Asg Superconductors S.P.A. | 2019-10-24 | Special | PDF ↗ |
| K183274 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2019-10-18 | Traditional | PDF ↗ |
| K192426 | Signa Voyager, Signa Voyager Quantum | Ge Healthcare (Tianjin) Company Limited | 2019-10-01 | Special | PDF ↗ |
| K191662 | Vantage Orian 1.5T, MRT-1550, V4.5 | Canon Medical Systems Corporation | 2019-07-23 | Special | PDF ↗ |
| K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow | Siemens Medical Solutions USA, Inc. | 2019-07-12 | Traditional | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.