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..

1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
409–432 of 1104
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
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 Nov 08, 2005
MODIFICATION TO: AURORA
K052698
Aurora Imaging Technology, Inc.
Radiology · 41d
Cleared Nov 08, 2005
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
K052987
Noras Rontgen-Und Medizintechnik GmbH
Radiology · 15d
Cleared Oct 17, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
K052571
Neurognostics, Inc.
Radiology · 28d
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 27, 2005
PORTAL GRAVITY SYSTEM
K052579
Portal, Inc.
Radiology · 7d
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