LNI — System, Nuclear Magnetic Resonance Spectroscopic Class II
FDA product code LNI covers "System, Nuclear Magnetic Resonance Spectroscopic", a Class II medical device regulated under 21 CFR 892.1000. Submissions are reviewed by the Radiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LNI
- Device Class
- Class II
- Regulation Number
- 892.1000
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093044 | hitachi medical systems america | OASIS MRI SYSTEM | March 16, 2010 |
| K071506 | hitachi medical systems america | ECHELON SPECTROSCOPY PACKAGE | June 28, 2007 |
| K011604 | ge medical systems | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI | August 22, 2001 |
| K010129 | toshiba america medical systems, in.c | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | April 5, 2001 |
| K003575 | ge medical systems | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | January 17, 2001 |
| K991568 | philips medical systems (cleveland) | MR SPECTROSCOPY PACKAGE | July 19, 1999 |
| K984167 | ge medical systems | SAGE 7 | January 12, 1999 |
| K962627 | siemens medical solutions usa | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM | April 3, 1997 |
| K970005 | elscint | GYREX 2T-PRESTIGE | March 28, 1997 |
| K930265 | ge medical systems | HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT | April 25, 1995 |