System, Nuclear Magnetic Resonance Spectroscopic
System, Nuclear Magnetic Resonance Spectroscopic is a system that uses NMR spectroscopy to analyze the chemical composition of tissues or body fluids in vivo or ex vivo, providing metabolic or biochemical information for diagnostic or research purposes, distinct from conventional MRI in that it generates spectral data rather than anatomical images. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LNI, regulated under 21 CFR 892.1000, within the Radiology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- LNI
- Device Class
- FDA class 2
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093044 | OASIS MRI SYSTEM | Mar 16, 2010 | Substantially Equivalent | Hitachi Medical Systems America, Inc. |
| K071506 | ECHELON SPECTROSCOPY PACKAGE | Jun 28, 2007 | Substantially Equivalent | Hitachi Medical Systems America, Inc. |
| K011604 | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI | Aug 22, 2001 | Substantially Equivalent | Ge Medical Systems, Inc. |
| K010129 | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | Apr 05, 2001 | Substantially Equivalent | Toshiba America Medical Systems, In.C |
| K003575 | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | Jan 17, 2001 | Substantially Equivalent | GE Medical Systems |
| K991568 | MR SPECTROSCOPY PACKAGE | Jul 19, 1999 | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. |
| K984167 | SAGE 7 | Jan 12, 1999 | Substantially Equivalent | GE Medical Systems |
| K962627 | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM | Apr 03, 1997 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K970005 | GYREX 2T-PRESTIGE | Mar 28, 1997 | Substantially Equivalent | Elscint, Inc. |
| K930265 | HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT | Apr 25, 1995 | Substantially Equivalent | GE Medical Systems |
FEI Numbers
This FDA classification entry is associated with 50 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.