FDA Product Code
FDA Product Code LNI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1000
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093044 | OASIS MRI SYSTEM | Hitachi Medical Systems America, Inc. | 2010-03-16 | Traditional | PDF ↗ |
| K071506 | ECHELON SPECTROSCOPY PACKAGE | Hitachi Medical Systems America, Inc. | 2007-06-28 | Abbreviated | PDF ↗ |
| K011604 | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI | Ge Medical Systems, Inc. | 2001-08-22 | Traditional | PDF ↗ |
| K010129 | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | Toshiba America Medical Systems, In.C | 2001-04-05 | Traditional | PDF ↗ |
| K003575 | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2001-01-17 | Traditional | PDF ↗ |
| K991568 | MR SPECTROSCOPY PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1999-07-19 | Traditional | PDF ↗ |
| K984167 | SAGE 7 | GE Medical Systems | 1999-01-12 | Traditional | PDF ↗ |
| K962627 | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-04-03 | Traditional | PDF ↗ |
| K970005 | GYREX 2T-PRESTIGE | Elscint, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K930265 | HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT | GE Medical Systems | 1995-04-25 | Traditional | PDF ↗ |
Product code LNI · Class II · Radiology. Data: openFDA.