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..

1110
Total
1110
Cleared
110d
Avg days
1988
Since
1110 devices
433–456 of 1110
Cleared Nov 20, 2007
FMRI HARDWARE SYSTEM
K073099
Nordicneurolab
Radiology · 18d
Cleared Nov 15, 2007
CHOY COMPRESSION FRAME
K070968
Choy Medical Technologies, Inc.
Radiology · 224d
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 May 22, 2007
NEURO II-SE, MODELS: OR-DR-OR, OR-MB
K071099
Imris, Inc.
Radiology · 33d
Cleared May 10, 2007
SUPERSTAR 0.35T MRI SYSTEM
K071154
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
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 Nov 03, 2006
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
K062454
Siemens Medi Cal Solutions, Inc.
Radiology · 73d
Cleared Oct 27, 2006
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
K062860
Neusoft Medical Systems Co., Ltd.
Radiology · 32d
Cleared Aug 11, 2006
NEURO II-SE, MODELS OR-MB-DR AND OR-DR
K061916
Imris, Inc.
Radiology · 36d
Cleared Jul 28, 2006
DIAGNOSOFT HARP
K061368
Diagnosoft, Inc.
Radiology · 73d
Cleared Jul 28, 2006
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
K061930
Fonar Corp.
Radiology · 21d
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 Jun 13, 2006
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
K061255
Kyron Clinical Imaging, Inc.
Radiology · 40d
Cleared May 24, 2006
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
K061132
Neusoft Medical Systems Co., Ltd.
Radiology · 30d
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 Jan 13, 2006
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
K052423
Siemens Medi Cal Solutions, Inc.
Radiology · 133d
Cleared Dec 08, 2005
CADIMAS VERSION 1.0
K052023
Alan Penn & Associates., Inc.
Radiology · 135d