ClearanceBrief
Panels › Radiology › Product code LNH · Class 2

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)
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Top companies in LNH

Company510(k)sRecalls
Philips North America0236
Siemens Medical Solutions13661
GE Medical Systems8280
GE Healthcare5123
Hitachi Medical Systems America, Inc.5423
Philips Medical Systems Nederlands B.V.367
Toshiba America Mri, Inc.620
Philips Medical Systems (Cleveland), Inc.574
Philips Medical Systems Nederland B.V.2714
Medical Advances, Inc.380
Decided510(k)Device and applicantCode
Jun 16, 1997K965044GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
Elscint, Inc.
LNH
Jun 5, 1997K970852MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
Siemens Medical Solutions USA, Inc.
LNH
May 29, 1997K963990GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
Philips Medical Systems, Inc.
LNH
Mar 28, 1997K963262ARTOSCAN M
Biosound, Inc.
LNH
Mar 12, 1997K970037TARGOGRID
Daum GmbH, DE
LNH
Feb 24, 1997K964778HI-STAR MRI IMAGING SYSTEM
Health Images, Inc.
LNH
Feb 24, 1997K964752KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER
Philips Medical Systems (Cleveland), Inc.
LNH
Feb 11, 1997K964753MATRIX 3000 FLEXIBLE SPINE COIL
Us Asia Instruments, Inc.
LNH
Feb 10, 1997K964626EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
Philips Medical Systems (Cleveland), Inc.
LNH
Feb 4, 1997K964608MRT-35A V9.0
Toshiba America Mri, Inc.
LNH
Jan 24, 1997K964531PROFILE 70000 QUADRATURE VOLUME NECK COIL
Us Asia Instruments, Inc.
LNH
Jan 17, 1997K964306MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
General Electric Co.
LNH
Jan 10, 1997K964370MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
LNH
Jan 10, 1997K962249PIXELL MRI SYSTEM
General Medical Equipment Corp.
LNH
Dec 23, 1996K962138FLEXART V3.1 SOFTWARE
Toshiba America Mri, Inc.
LNH
Dec 18, 1996K963953IMIG-MRI
Imig-Mri Systems, LLC
LNH
Nov 27, 1996K963429MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
LNH
Nov 27, 1996K962061MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
LNH
Nov 12, 1996K963186ORTHO 8000
Inner Vision Mri , Ltd.
LNH
Nov 7, 1996K963179MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
LNH
Oct 29, 1996K962892HELAX TMS BRACHYTHERAPY, VERSION 3.0
Siemens Medical Solutions USA, Inc.
LNH
Oct 25, 1996K962933OPART MRT-600
Toshiba America Mri, Inc.
LNH
Oct 18, 1996K963345ADVANTAGE WINDOWS TISSUE VOLUME OPTION
GE Medical Systems
LNH
Oct 18, 1996K961624FLEXART TMJ COIL
Toshiba America Mri, Inc.
LNH
Sep 25, 1996K962927IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
Siemens Medical Solutions USA, Inc.
LNH
Sep 20, 1996K962677ESTEEM 1.5T MRI SYSTEM
Elscint Mr, Inc.
LNH
Sep 5, 1996K961969HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE
Hitachi Medical Systems America, Inc.
LNH
Sep 4, 1996K962618GYREX V-EP
Elscint, Inc.
LNH
Aug 27, 1996K962117QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
Philips Medical Systems (Cleveland), Inc.
LNH
Aug 14, 1996K9620481W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
Hitachi Medical Systems America, Inc.
LNH
Aug 2, 1996K961842SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM
Toshiba America Mri, Inc.
LNH
Jul 25, 1996K961876AIRIS
Hitachi Medical Systems America, Inc.
LNH
Jul 5, 1996K960497FLEXIBLE PHASED ARRAY SPINE COIL
Philips Medical Systems (Cleveland), Inc.
LNH
Jul 3, 1996K961366MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
Mri Devices Corp.
LNH
Jun 28, 1996K961238MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1
Toshiba America Mri, Inc.
LNH
Jun 21, 1996K961174ECG MONITOR MODEL DS-3130/3140
Hitachi Medical Systems America, Inc.
LNH
Jun 19, 1996K961121KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM
Siemens Medical Solutions USA, Inc.
LNH
Jun 14, 1996K961092VISART
Toshiba America Medical Systems, In.C
LNH
Jun 10, 1996K955389MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
Siemens Medical Solutions USA, Inc.
LNH
May 29, 1996K960973MOVABLE ADD-ON COUCH FOR OUTLOOK
Philips Medical Systems (Cleveland), Inc.
LNH
May 29, 1996K960901MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
Medrad, Inc.
LNH
Apr 19, 1996K960294PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
Philips Medical Systems (Cleveland), Inc.
LNH
Apr 12, 1996K954354MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
General Electric Co.
LNH
Apr 12, 1996K954353MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
General Electric Co.
LNH
Mar 29, 1996K955811AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
Siemens Medical Solutions USA, Inc.
LNH
Mar 5, 1996K960181VERSION 3.7 OPERATING SYSTEM SOFTWARE
Hitachi Medical Systems America, Inc.
LNH
Feb 26, 1996K950837AURORA IMAGING SYSTEM
Advanced Mammography Systems, Inc.
LNH
Jan 18, 1996K954646EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
Philips Medical Systems (Cleveland), Inc.
LNH
Dec 22, 1995K945945GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
Philips Medical Systems North America, Inc.
LNH
Nov 24, 1995K954039GYREX PRIVILEGE
Elscint, Inc.
LNH

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