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
337–360 of 1104
Cleared Jan 17, 2013
BRIVO MR355, OPTIMA MR360
K123417
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 72d
Cleared Dec 13, 2012
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
K122613
Toshiba America Medical Systems, In.C
Radiology · 108d
Cleared Dec 11, 2012
MAVRIC SL
K113394
Ge Medical Systems, LLC
Radiology · 391d
Cleared Dec 06, 2012
MRJ 3300
K122034
Paramed S.R.L.
Radiology · 148d
Cleared Nov 13, 2012
OPTIMA MR 430S
K123068
Ge Medical Systems, LLC
Radiology · 43d
Cleared Nov 05, 2012
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
K121434
Siemens Medi Cal Solutions, Inc.
Radiology · 175d
Cleared Sep 21, 2012
PRISM ACQUIRE PRISM PROCESS PRISM VIEW
K122026
Prism Clinical Imaging, Inc.
Radiology · 72d
Cleared Sep 20, 2012
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
K121676
Ge Medical Systems, LLC
Radiology · 105d
Cleared Aug 10, 2012
IMRIS ONCOLOGY PACKAGE
K121997
Imris, Inc.
Radiology · 32d
Cleared Aug 06, 2012
G-SCAN BRIO
K122006
Esaote, S.P.A.
Radiology · 28d
Cleared Jul 16, 2012
MAGNETOM SPECTRA
K121160
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jul 09, 2012
S-SCAN
K121650
Esaote, S.P.A.
Radiology · 34d
Cleared Jun 08, 2012
BELLYBOARD, SBRT ACCESSORIES
K121545
Medtec Inc. Dba Civco Medical Solutions
Radiology · 14d
Cleared Jun 01, 2012
VANTAGE TITAN
K120638
Toshibamedical Systems Corporation
Radiology · 92d
Cleared May 24, 2012
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE
K121239
Optoacoustics, Ltd.
Radiology · 30d
Cleared May 23, 2012
VANTAGE TITAN 3T
K120487
Toshibamedical Systems Corporation
Radiology · 96d
Cleared May 17, 2012
MRI SYTEMS
K113281
Shenzhen Anke High-Tech Co., Ltd.
Radiology · 192d
Cleared May 02, 2012
ECHOSTAR SPICA 1.5T MR SYSTEM
K113511
Alltech Medical Systems America, Inc.
Radiology · 156d
Cleared May 01, 2012
ECHELON OVAL MRI SYSTEM
K113145
Hitachi Medical Systems America, Inc.
Radiology · 189d
Cleared May 01, 2012
SPEEDUP SOFTWARE OPTION
K120748
Esaote, S.P.A.
Radiology · 50d
Cleared Mar 27, 2012
BRIVO MR355
K120778
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 13d
Cleared Jan 13, 2012
VANTAGE TITAN 3T
K113093
Toshibamedical Systems Corporation
Radiology · 86d
Cleared Jan 13, 2012
OPTIMA MR450W
K113490
Ge Medical Systems, LLC
Radiology · 51d
Cleared Dec 30, 2011
VISIA DYNAMIC REVIEW
K113337
Mevis Medical Solutions AG
Radiology · 46d