FDA 510(k) Applications for Medical Device Product Code "LNI"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K970005 | ELSCINT, INC. | GYREX 2T-PRESTIGE | 03/28/1997 |
K003575 | GE MEDICAL SYSTEMS | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | 01/17/2001 |
K984167 | GE MEDICAL SYSTEMS | SAGE 7 | 01/12/1999 |
K011604 | GE MEDICAL SYSTEMS, INC. | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI | 08/22/2001 |
K071506 | HITACHI MEDICAL SYSTEMS AMERICA, INC. | ECHELON SPECTROSCOPY PACKAGE | 06/28/2007 |
K093044 | HITACHI MEDICAL SYSTEMS AMERICA, INC. | OASIS MRI SYSTEM | 03/16/2010 |
K991568 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | MR SPECTROSCOPY PACKAGE | 07/19/1999 |
K962627 | SIEMENS MEDICAL SOLUTIONS USA, INC. | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM | 04/03/1997 |
K010129 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | 04/05/2001 |