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
Cleared
Jan 17, 2013
BRIVO MR355, OPTIMA MR360
Ge Hangwei Medical Systems Co., Ltd.
Radiology
72d
Cleared
Dec 13, 2012
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
Toshiba America Medical Systems, In.C
Radiology
108d
Cleared
Dec 11, 2012
MAVRIC SL
Ge Medical Systems, LLC
Radiology
391d
Cleared
Dec 06, 2012
MRJ 3300
Paramed S.R.L.
Radiology
148d
Cleared
Nov 13, 2012
OPTIMA MR 430S
Ge Medical Systems, LLC
Radiology
43d
Cleared
Nov 05, 2012
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
Siemens Medi Cal Solutions, Inc.
Radiology
175d
Cleared
Sep 21, 2012
PRISM ACQUIRE PRISM PROCESS PRISM VIEW
Prism Clinical Imaging, Inc.
Radiology
72d
Cleared
Sep 20, 2012
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
Ge Medical Systems, LLC
Radiology
105d
Cleared
Aug 10, 2012
IMRIS ONCOLOGY PACKAGE
Imris, Inc.
Radiology
32d
Cleared
Aug 06, 2012
G-SCAN BRIO
Esaote, S.P.A.
Radiology
28d
Cleared
Jul 16, 2012
MAGNETOM SPECTRA
Siemens Medical Solutions USA, Inc.
Radiology
91d
Cleared
Jul 09, 2012
S-SCAN
Esaote, S.P.A.
Radiology
34d
Cleared
Jun 08, 2012
BELLYBOARD, SBRT ACCESSORIES
Medtec Inc. Dba Civco Medical Solutions
Radiology
14d
Cleared
Jun 01, 2012
VANTAGE TITAN
Toshibamedical Systems Corporation
Radiology
92d
Cleared
May 24, 2012
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE
Optoacoustics, Ltd.
Radiology
30d
Cleared
May 23, 2012
VANTAGE TITAN 3T
Toshibamedical Systems Corporation
Radiology
96d
Cleared
May 17, 2012
MRI SYTEMS
Shenzhen Anke High-Tech Co., Ltd.
Radiology
192d
Cleared
May 02, 2012
ECHOSTAR SPICA 1.5T MR SYSTEM
Alltech Medical Systems America, Inc.
Radiology
156d
Cleared
May 01, 2012
ECHELON OVAL MRI SYSTEM
Hitachi Medical Systems America, Inc.
Radiology
189d
Cleared
May 01, 2012
SPEEDUP SOFTWARE OPTION
Esaote, S.P.A.
Radiology
50d
Cleared
Mar 27, 2012
BRIVO MR355
Ge Hangwei Medical Systems Co., Ltd.
Radiology
13d
Cleared
Jan 13, 2012
VANTAGE TITAN 3T
Toshibamedical Systems Corporation
Radiology
86d
Cleared
Jan 13, 2012
OPTIMA MR450W
Ge Medical Systems, LLC
Radiology
51d
Cleared
Dec 30, 2011
VISIA DYNAMIC REVIEW
Mevis Medical Solutions AG
Radiology
46d