FDA 510(k) Applications for Medical Device Product Code "LNI"
(System, Nuclear Magnetic Resonance Spectroscopic)

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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact