LNI · System, Nuclear Magnetic Resonance Spectroscopic
Radiology · 21 CFR 892.1000 · Class 2
Overview
| Product Code | LNI |
|---|---|
| Device Name | System, Nuclear Magnetic Resonance Spectroscopic |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
Classification Rationale
Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K093044 | OASIS MRI SYSTEM | Hitachi Medical Systems America, Inc. | Mar 16, 2010 | SESE |
| K071506 | ECHELON SPECTROSCOPY PACKAGE | Hitachi Medical Systems America, Inc. | Jun 28, 2007 | SESE |
| K011604 | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI | Ge Medical Systems, Inc. | Aug 22, 2001 | SESE |
| K010129 | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | Toshiba America Medical Systems, In.C | Apr 5, 2001 | SESE |
| K003575 | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | GE Medical Systems | Jan 17, 2001 | SESE |
| K991568 | MR SPECTROSCOPY PACKAGE | Philips Medical Systems (Cleveland), Inc. | Jul 19, 1999 | SESE |
| K984167 | SAGE 7 | GE Medical Systems | Jan 12, 1999 | SESE |
| K962627 | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM | Siemens Medical Solutions USA, Inc. | Apr 3, 1997 | SESE |
| K970005 | GYREX 2T-PRESTIGE | Elscint, Inc. | Mar 28, 1997 | SESE |
| K930265 | HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT | GE Medical Systems | Apr 25, 1995 | SESE |
Top Applicants
- GE Medical Systems — 3 clearances
- Hitachi Medical Systems America, Inc. — 2 clearances
- Toshiba America Medical Systems, In.C — 1 clearance
- Siemens Medical Solutions USA, Inc. — 1 clearance
- Philips Medical Systems (Cleveland), Inc. — 1 clearance
