Product code LNH
- Device name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1000
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P830074S017 | GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS | General Electric Co. | 1988-07-29 |
| P860062S002 | RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST | Resonex, Inc. | 1988-07-27 |
| P830053S030 | DIASONICS NMR IMAGING SYSTEM | Diasonics, Inc. | 1988-07-27 |
| P830052S019 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. | 1988-07-27 |
| P830081S022 | MAGNETOM | Siemens Corp. | 1988-07-25 |
| P830074S013 | GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS | General Electric Co. | 1988-07-15 |
| P830052S022 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| P830052S021 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| P830051S015 | TESLACON(TM) NMR IMAGING SYSTEM | Technicare Corp. | 1988-07-14 |
| P830081S019 | MAGNETOM | Siemens Corp. | 1988-07-12 |
| P830076S012 | FONAR NMR WHOLE BODY SCANNER BETA 3000 | Fonar Corp. | 1988-07-12 |
| P830053S029 | DIASONICS NMR IMAGING SYSTEM | Diasonics, Inc. | 1988-07-07 |
| P830074S016 | GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS | General Electric Co. | 1988-06-30 |
| P830052S018 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. | 1988-06-13 |
| P860010S003 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM | Palomex Instrumentarium Corp. | 1988-06-12 |
| P860062S001 | RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST | Resonex, Inc. | 1988-05-25 |
| P830081S018 | MAGNETOM | Siemens Corp. | 1988-05-24 |
| P830076S013 | FONAR NMR WHOLE BODY SCANNER BETA 3000 | Fonar Corp. | 1988-05-24 |
| P830052S017 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| P830052S015 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| P840063S006 | GYROSCAN(TM) | Philips Medical Systems, Inc. | 1988-05-05 |
| P830074S014 | GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS | General Electric Co. | 1988-05-05 |
| P840063S007 | GYROSCAN(TM) | Philips Medical Systems, Inc. | 1988-05-02 |
| P830074S015 | GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS | General Electric Co. | 1988-05-02 |
| P830052S016 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. | 1988-04-28 |
| P840007S003 | GYREX | Elscint, Inc. | 1988-04-26 |
| P830052S014 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. | 1988-04-26 |
| P830052S013 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. | 1988-04-26 |
| P830081S017 | MAGNETOM | Siemens Corp. | 1988-04-15 |
| P830076S009 | FONAR NMR WHOLE BODY SCANNER BETA 3000 | Fonar Corp. | 1988-04-15 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-04-06 |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026-03-27 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2026-03-27 |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026-03-20 |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026-03-13 |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026-03-09 |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | 2026-03-05 |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 |
| 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 |
| K253780 | SIGNA™ Bolt | Ge Medical Systems, LLC | 2026-02-06 |
| K253779 | SIGNA™ Sprint Select | Ge Medical Systems, LLC | 2026-02-05 |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | 2026-01-26 |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 2025-12-23 |
| 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 |
| K253489 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025-12-12 |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-11-20 |
| K252371 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-25 |
| K251386 | ECHELON Synergy | Fujifilm Corporation | 2025-09-17 |
| K251399 | SIGNA™ Sprint | Ge Medical Systems, LLC | 2025-09-11 |
| K251682 | MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) | 2025-09-09 |
| K251029 | Vista OS, Vista AI Scan, RTHawk | Vista AI, Inc. | 2025-08-21 |
| K252239 | InVision™ 3T Recharge Operating Suite | Imris Imaging, Inc. | 2025-08-06 |
| K250246 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | 2025-08-05 |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2025-07-22 |
| K243547 | uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| K243397 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-16 |
| 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 |
| K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-06-16 |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | Siemens Healthcare GmbH | 2025-06-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08720168162595 | Mask DSPS®-PROSH set/5 | MACROMEDICS B.V. | 2026-04-23 |
| 08720168163394 | DSPS PRO Mask Shim Set HO | MACROMEDICS B.V. | 2026-04-22 |
| 08720168163387 | DSPS PRO Mask Shim Set HNS | MACROMEDICS B.V. | 2026-04-22 |
| 08720168163356 | DSPS-Prominent® SH profile set/2 | MACROMEDICS B.V. | 2026-04-22 |
| 08720168162571 | Mask DSPS®-PROSHVRL set/5 | MACROMEDICS B.V. | 2026-04-22 |
| 08720168162618 | Mask DSPS®-PROSHL set/5 | MACROMEDICS B.V. | 2026-04-22 |
| 08720168162649 | Mask DSPS®-PROSHVR set/5 | MACROMEDICS B.V. | 2026-04-22 |
| 08720168162748 | Mask DSPS®-PROH, set/5 | MACROMEDICS B.V. | 2026-04-22 |
| 08720168162755 | Mask DSPS®-PRO, set/5 | MACROMEDICS B.V. | 2026-04-22 |
| 08720168162854 | Mask DSPS®-PROSCVRL set/5 | MACROMEDICS B.V. | 2026-04-22 |
| 08720168162861 | Mask DSPS®-PROSC set/5 | MACROMEDICS B.V. | 2026-04-22 |
| 08720168162878 | Mask DSPS®-PROSCVR set/5 | MACROMEDICS B.V. | 2026-04-22 |
| 08720168162885 | Mask DSPS®-PROSCL set/5 | MACROMEDICS B.V. | 2026-04-22 |
| 08056304455727 | G-scan Open | ESAOTE SPA | 2024-07-02 |
| 09355529000002 | FerriScan, Cardiac T2* | RESONANCE HEALTH ANALYSIS SERVICES PTY LTD | 2023-06-19 |
| 10841439101534 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-09-25 |
| 10841439101510 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-09-25 |
| 10841439101572 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-09-25 |
| 10841439101503 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-09-25 |
| 10841439101541 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-09-25 |
| 10841439101558 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-09-25 |
| 10841439101565 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-09-25 |
| 10841439101497 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-09-25 |
| 10841439101480 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-09-25 |
| 10841439101527 | Posicast® Thermoplastic | MEDTEC, INC. | 2017-08-30 |
| 10841436103128 | omniTRAX Active Patient Tracker | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 08056304451095 | S-scan | ESAOTE SPA | 2016-09-27 |
| 08056304450081 | O-scan | ESAOTE SPA | 2016-09-27 |
| 08056304450074 | S-scan | ESAOTE SPA | 2016-09-27 |
| 08056304450029 | G-scan Brio | ESAOTE SPA | 2016-09-27 |