LNH · Class II · 21 CFR 892.1000

FDA Product Code LNH: System, Nuclear Magnetic Resonance Imaging

FDA product code LNH covers magnetic resonance imaging (MRI) systems.

These diagnostic imaging systems use strong magnetic fields and radiofrequency pulses to generate detailed cross-sectional images of soft tissue, organs, and musculoskeletal structures without ionizing radiation. MRI is widely used in neurology, oncology, and orthopedics.

LNH devices are Class II medical devices, regulated under 21 CFR 892.1000 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Toshiba America Mri, Inc. and Philips Medical Systems (Cleveland), Inc..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
337–360 of 1101
Cleared Jan 22, 2008
VANTAGE TITAN, MODEL MRT-1504/S3
K080038
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jan 04, 2008
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
K073167
Ge Medical Systems, LLC
Radiology · 56d
Cleared Nov 21, 2007
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
K073081
Toshiba America Medical Systems, In.C
Radiology · 20d
Cleared Nov 01, 2007
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
K072998
Ge Medical Systems, LLC
Radiology · 8d
Cleared Oct 10, 2007
MAGNETOM VERIO
K072237
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Sep 21, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K072279
Hitachi Medical Systems America, Inc.
Radiology · 36d
Cleared Aug 14, 2007
MAGNETOM ESSENZA
K071925
Siemens Medical Solutions USA, Inc.
Radiology · 33d
Cleared Jan 04, 2007
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
K063559
Philips Medical Systems
Radiology · 38d
Cleared Nov 21, 2006
EXCELART VANTAGE ATLAS, MODEL MRT-1503
K063361
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 09, 2006
S-SCAN MRI SYSTEM
K063207
Esaote, S.P.A.
Radiology · 17d
Cleared Jul 25, 2006
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
K061429
Esaote, S.P.A.
Radiology · 63d
Cleared May 04, 2006
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
K060956
Esaote, S.P.A.
Radiology · 27d
Cleared Jan 24, 2006
ALTAIRE INTERVENTIONAL MR PACKAGE
K053309
Hitachi Medical Systems America, Inc.
Radiology · 57d
Cleared Jan 18, 2006
EXCELART VANTAGE ZGV
K060003
Toshibamedical Systems Corporation
Radiology · 15d
Cleared Nov 17, 2005
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009
GE Medical Systems
Radiology · 22d
Cleared Nov 09, 2005
GE 1.5T SIGNA HDE MR SYSTEM
K052978
Ge Medical Systems, LLC
Radiology · 16d
Cleared Oct 04, 2005
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
K052164
Siemens Medical Solutions USA, Inc.
Radiology · 56d
Cleared Sep 27, 2005
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
K052172
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared Sep 22, 2005
SIMTEC IM-MAXX 2 OPTION
K052315
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Sep 21, 2005
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
K052293
Ge Medical Systems, LLC
Radiology · 29d
Cleared Sep 08, 2005
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
K052305
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Sep 07, 2005
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
K052078
Philips Medical Systems Nederland B.V.
Radiology · 37d
Cleared Aug 02, 2005
ACHIEVA 1.5T & INERA 1.5T FAMILY
K052013
Philips Medical Systems Nederland B.V.
Radiology · 7d
Cleared Apr 07, 2005
ALTAIRE
K050602
Hitachi Medical Systems America, Inc.
Radiology · 29d