Product code LNI
- Device name
- System, Nuclear Magnetic Resonance Spectroscopic
- 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 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093044 | OASIS MRI SYSTEM | Hitachi Medical Systems America, Inc. | 2010-03-16 |
| K071506 | ECHELON SPECTROSCOPY PACKAGE | Hitachi Medical Systems America, Inc. | 2007-06-28 |
| K011604 | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI | Ge Medical Systems, Inc. | 2001-08-22 |
| K010129 | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | Toshiba America Medical Systems, In.C | 2001-04-05 |
| K003575 | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2001-01-17 |
| K991568 | MR SPECTROSCOPY PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1999-07-19 |
| K984167 | SAGE 7 | GE Medical Systems | 1999-01-12 |
| K962627 | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-04-03 |
| K970005 | GYREX 2T-PRESTIGE | Elscint, Inc. | 1997-03-28 |
| K930265 | HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT | GE Medical Systems | 1995-04-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195278925282 | NA | GE HEALTHCARE(TIANJIN) COMPANY LIMITED | 2026-05-11 |
| 00008848380988 | Ingenia | Philips Medical Systems Nederland B.V. | 2025-10-01 |
| 00195278929518 | NA | GE HEALTHCARE(TIANJIN) COMPANY LIMITED | 2025-09-26 |
| 00857534006851 | InVision™ 3T Recharge Operating Suite | IMRIS Imaging, Inc. | 2025-09-18 |
| 00195278483713 | NA | GE Medical Systems, L.L.C. | 2025-05-07 |
| 00860013965204 | BrainSpec Core™ Software | BrainSpec Inc. | 2025-05-01 |
| 00198715251623 | BrainSpec Core™ Software | BrainSpec Inc. | 2025-02-10 |
| 00857534006813 | InVision™ 1.5T Operating Suite | IMRIS Imaging, Inc. | 2024-03-22 |
| 00857534006806 | InVision™ 3T Operating Suite | IMRIS Imaging, Inc. | 2024-03-22 |
| 00857534006776 | InVision 1.5 Surgical Theatre | IMRIS Imaging, Inc. | 2024-02-26 |
| 00195278486813 | NA | GE Medical Systems, L.L.C. | 2022-02-11 |
| 00857534006745 | IMRIS iMRI 3T V | IMRIS Imaging, Inc. | 2021-10-28 |
| 00884838098275 | Ingenia | Philips Medical Systems Nederland B.V. | 2021-05-01 |
| 00195278010797 | NA | GE Medical Systems, L.L.C. | 2020-08-14 |
| 00884838009820 | Ingenia | Philips Medical Systems Nederland B.V. | 2019-10-01 |
| 00884838095083 | Ingenia | Philips Medical Systems Nederland B.V. | 2019-09-23 |
| 00884838090057 | Ingenia | Philips Medical Systems Nederland B.V. | 2018-08-30 |
| 00884838090040 | Ingenia | Philips Medical Systems Nederland B.V. | 2018-08-30 |
| 00884838088108 | Ingenia Elition S | Philips Medical Systems Nederland B.V. | 2018-05-01 |
| 00884838088115 | Ingenia | Philips Medical Systems Nederland B.V. | 2018-04-25 |
| 00840682135269 | NA | GE Medical Systems, L.L.C. | 2017-12-11 |
| 00884838068452 | Ingenia | Philips Medical Systems Nederland B.V. | 2016-09-23 |
| 00884838082625 | Philips | Philips Oy | 2016-09-23 |
| 00884838082618 | Ingenia MR-OR | Philips Oy | 2016-09-23 |
| 00884838068421 | Ingenia 1.5T S | Philips Medical Systems Nederland B.V. | 2016-09-23 |
| 00884838055339 | Ingenia | Philips Medical Systems Nederland B.V. | 2016-09-23 |
| 00840682109741 | NA | USA INSTRUMENTS, INC. | 2016-08-01 |
| 00840682115889 | NA | GE Medical Systems, L.L.C. | 2016-08-01 |
| 00840682115964 | NA | GE Medical Systems, L.L.C. | 2016-08-01 |
| 00840682116787 | NA | GE Medical Systems, L.L.C. | 2016-08-01 |