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
505–528 of 1110
Cleared Aug 21, 2003
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
K032490
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Aug 13, 2003
MODIFICATION TO E-SCAN XQ
K032121
Esaote, S.P.A.
Radiology · 35d
Cleared Jul 30, 2003
MR FIBER OPTIC ECG GATING SYSTEM
K031731
Sa Instruments, Inc.
Radiology · 56d
Cleared Jul 30, 2003
AURORA
K032082
Aurora Imaging Technology, Inc.
Radiology · 23d
Cleared Jul 02, 2003
GE DELTA SOFTWARE OPTION FOR MRI
K031927
GE Medical Systems
Radiology · 9d
Cleared Jun 24, 2003
ECLIPSE
K030981
Varian Medical Systems, Inc.
Radiology · 88d
Cleared Jun 23, 2003
3TP SOFTWARE OPTION
K031350
3tp, LLC
Radiology · 55d
Cleared May 13, 2003
ADVANTAGE WORKSTATION PASTING 1.1
K031396
GE Medical Systems
Radiology · 11d
Cleared May 02, 2003
GE PROPELLER IMAGING OPTION FOR MRI
K031230
GE Medical Systems
Radiology · 14d
Cleared Apr 01, 2003
SUPEROPEN 0.35T, MODEL NSM-P035
K030918
Neusoft Digital Medical Systems Co., Ltd.
Radiology · 8d
Cleared Mar 28, 2003
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
K030874
General Electric Co.
Radiology · 8d
Cleared Mar 06, 2003
INTERA FAMILY
K030520
Philips Medical Systems North America Co.
Radiology · 15d
Cleared Feb 04, 2003
PANORAMA ENHANCEMENTS
K024042
Philips Medical Systems, Inc.
Radiology · 60d
Cleared Feb 04, 2003
INFINION SOFTWARE FEATURES
K024066
Philips Medical Systems (Cleveland), Inc.
Radiology · 57d
Cleared Jan 29, 2003
AURORA MR-GUIDED INTERVENTIONAL SYSTEM
K023686
Aurora Imaging Technology, Inc.
Radiology · 89d
Cleared Nov 05, 2002
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
K023511
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Oct 11, 2002
HITACHI ALTAIRE
K022390
Hitachi Medical Systems America, Inc.
Radiology · 80d
Cleared Oct 11, 2002
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
K023130
Mri Devices Corp.
Radiology · 21d
Cleared Oct 09, 2002
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
K023207
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Aug 28, 2002
RF TENT
K022157
Odin Medical Technologies , Ltd.
Radiology · 57d
Cleared Aug 22, 2002
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
K022397
GE Medical Systems
Radiology · 30d
Cleared Jun 13, 2002
SYNGO MR 2002B
K020991
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Apr 25, 2002
ISAAC 1.5 T MR SYSTEM
K020268
Chi, Inc.
Radiology · 90d
Cleared Apr 24, 2002
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
K020289
Machnet BV
Radiology · 86d