LNI — System, Nuclear Magnetic Resonance Spectroscopic Class II
FDA Device Classification
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 |