System, Nuclear Magnetic Resonance Imaging
Regulation 892.1000
28510(k)s in 12 months (1,110 all time)
60recalls in 12 months (723 all time)
630recalls that name a 510(k)
Top companies in LNH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 1999 | K991943 | MRGP OPTICAL TRACKING UNIT Philips Medical Systems (Cleveland), Inc. | LNH |
| Aug 17, 1999 | K992412 | IPASS BOLUS TRACKING Philips Medical Systems (Cleveland), Inc. | LNH |
| Aug 13, 1999 | K992120 | DYNAWELL OR DYNAWELL Ekeroth Quality AB, SE | LNH |
| Aug 3, 1999 | K991652 | HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM Siemens Corp. | LNH |
| Jun 18, 1999 | K991243 | NORMA 10 Odin Technologies , Ltd., IL | LNH |
| May 27, 1999 | K990968 | E-SCAN Biosound Esaote, Inc. | LNH |
| May 14, 1999 | K990620 | EXCELART Toshiba America Mri, Inc. | LNH |
| May 11, 1999 | K990550 | 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM Ge Medical Systems, Inc. | LNH |
| Apr 15, 1999 | K990260 | OPART Toshiba America Mri, Inc. | LNH |
| Feb 25, 1999 | K983110 | FLEXART,FLEXART/HYPER, VISART, VISART/HYPER Toshiba America Mri, Inc. | LNH |
| Feb 12, 1999 | K984221 | FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR Siemens Corp. | LNH |
| Feb 8, 1999 | K984280 | AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE Hitachi Medical Systems America, Inc. | LNH |
| Feb 2, 1999 | K984224 | PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS Siemens Corp. | LNH |
| Jan 25, 1999 | K984274 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE Hitachi Medical Systems America, Inc. | LNH |
| Jan 7, 1999 | K983902 | FIELD EFFECTS MRI SYSTEM Intermagnetics General Corp. | LNH |
| Nov 3, 1998 | K982959 | MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC Medrad, Inc. | LNH |
| Nov 2, 1998 | K982932 | MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC Medrad, Inc. | LNH |
| Oct 29, 1998 | K982834 | RESTGRID PACKAGE/GYROSCAN NT Philips Medical Systems North America, Inc. | LNH |
| Oct 22, 1998 | K982761 | JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031 Chamco, Inc. | LNH |
| Oct 9, 1998 | K983327 | ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS Siemens Medical Solutions USA, Inc. | LNH |
| Sep 2, 1998 | K982157 | TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE Field Effects | LNH |
| Aug 27, 1998 | K980831 | IMAGE POST-PROCESSING TECHNIQUES Philips Medical Systems (Cleveland), Inc. | LNH |
| Aug 3, 1998 | K981898 | ORTHOVU-1000 Magnevu | LNH |
| Jul 14, 1998 | K981475 | OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE Toshiba America Mri, Inc. | LNH |
| Jun 30, 1998 | K981410 | HAMMERSMITH ENDOCAVITARY COILS Philips Medical Systems (Cleveland), Inc. | LNH |
| Jun 30, 1998 | K981190 | HIGH IMPEDANCE CARDIAC GATING CABLE GE Medical Systems | LNH |
| Jun 1, 1998 | K981398 | ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM Interneuron Pharmaceuticals, Inc. | LNH |
| May 11, 1998 | K980645 | PHILIPS GYROSCAN NT RELEASE 6 SERIES Philips Medical Systems North America, Inc. | LNH |
| May 6, 1998 | K973658 | DIFFUSION PACKAGE / GYROSCAN NT Philips Medical Systems North America, Inc. | LNH |
| May 4, 1998 | K980417 | MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V Medrad, Inc. | LNH |
| Apr 2, 1998 | K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP Elscint, Inc. | LNH |
| Mar 30, 1998 | K980114 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE Medical Systems | LNH |
| Mar 10, 1998 | K974844 | OUTLOOK SYSTEM ENHANCEMENT PACKAGE Philips Medical Systems (Cleveland), Inc. | LNH |
| Mar 4, 1998 | K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 Elscint, Inc. | LNH |
| Feb 26, 1998 | K974498 | STRATIS II Hitachi Medical Systems America, Inc. | LNH |
| Feb 9, 1998 | K974212 | AIRIS II Hitachi Medical Systems America, Inc. | LNH |
| Feb 6, 1998 | K974530 | DUFFUSION-WEIGHTED MR IMAGING PACKAGE Philips Medical Systems (Cleveland), Inc. | LNH |
| Feb 5, 1998 | K972990 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE Medical Systems | LNH |
| Jan 2, 1998 | K973799 | CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT Siemens Medical Solutions USA, Inc. | LNH |
| Oct 15, 1997 | K972826 | ESTEEM 1.5T MRI SYSTEM Elscint Mr, Inc. | LNH |
| Sep 29, 1997 | K972704 | KINEMATIC POSITIONERS Ge Medical Systems, Inc. | LNH |
| Aug 25, 1997 | K970990 | GYREX PRIMA 1TG 1.0T MRI SYSTEM Elscint Mr, Inc. | LNH |
| Aug 20, 1997 | K971884 | ASSET APOLLO Philips Medical Systems (Cleveland), Inc. | LNH |
| Aug 5, 1997 | K971684 | MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) Siemens Medical Solutions USA, Inc. | LNH |
| Jul 24, 1997 | K971668 | SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS GE Medical Systems | LNH |
| Jul 21, 1997 | K970573 | FLEXART V3.5 SOFTWARE Toshiba America Mri, Inc. | LNH |
| Jul 15, 1997 | K965068 | MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE Toshiba America Medical Systems, In.C | LNH |
| Jul 3, 1997 | K971380 | MEDRAD FLEX INTERFACE DEVICE Medrad, Inc. | LNH |
| Jul 3, 1997 | K971279 | VERSION 4 OPERATING SYSTEM SOFTWARE Hitachi Medical Systems America, Inc. | LNH |
| Jun 20, 1997 | K971055 | DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION Siemens Medical Solutions USA, Inc. | LNH |
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