Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1000](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1000) → LNI — System, Nuclear Magnetic Resonance Spectroscopic

# LNI · System, Nuclear Magnetic Resonance Spectroscopic

_Radiology · 21 CFR 892.1000 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI

## Overview

- **Product Code:** LNI
- **Device Name:** System, Nuclear Magnetic Resonance Spectroscopic
- **Regulation:** [21 CFR 892.1000](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1000)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K093044.md) | OASIS MRI SYSTEM | Hitachi Medical Systems America, Inc. | Mar 16, 2010 | SESE |
| [K071506](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K071506.md) | ECHELON SPECTROSCOPY PACKAGE | Hitachi Medical Systems America, Inc. | Jun 28, 2007 | SESE |
| [K011604](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K011604.md) | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION  FOR MRI | Ge Medical Systems, Inc. | Aug 22, 2001 | SESE |
| [K010129](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K010129.md) | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | Toshiba America Medical Systems, In.C | Apr 5, 2001 | SESE |
| [K003575](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K003575.md) | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | GE Medical Systems | Jan 17, 2001 | SESE |
| [K991568](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K991568.md) | MR SPECTROSCOPY PACKAGE | Philips Medical Systems (Cleveland), Inc. | Jul 19, 1999 | SESE |
| [K984167](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K984167.md) | SAGE 7 | GE Medical Systems | Jan 12, 1999 | SESE |
| [K962627](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K962627.md) | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM | Siemens Medical Solutions USA, Inc. | Apr 3, 1997 | SESE |
| [K970005](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K970005.md) | GYREX 2T-PRESTIGE | Elscint, Inc. | Mar 28, 1997 | SESE |
| [K930265](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K930265.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI)

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