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
Cleared
Mar 20, 2018
Ingenia Elition S and Ingenia Elition X
Philips Medical Systems Nederland B.V.
Radiology
134d
Cleared
Mar 14, 2018
MR Wireless Gating System, Model WGS-100
Ivy Biomedical Systems, Inc.
Radiology
272d
Cleared
Mar 06, 2018
Ingenia Elition S and Ingenia Elition X R5.4
Philips Medical Systems Nederland B.V.
Radiology
132d
Cleared
Feb 23, 2018
SPIN-SWI
Spintech, Inc.
Radiology
143d
Cleared
Feb 16, 2018
Wireless Audio System
Neocoil, LLC
Radiology
107d
Cleared
Feb 13, 2018
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
Siemens Medical Solutions USA, Inc.
Radiology
84d
Cleared
Jan 26, 2018
Vantage Galan 3T, V4.6
Toshibamedical Systems Corporation
Radiology
88d
Cleared
Jan 26, 2018
SyMRI
Syntheticmr AB
Radiology
70d
Cleared
Jan 22, 2018
3D APT
Philips Medical Systems Nederland B.V.
Radiology
119d
Cleared
Jan 11, 2018
ECHELON OVAL V6.0A MRI System
Hitachi Healthcare Americas Corporation
Radiology
182d
Cleared
Dec 19, 2017
MAGNETOM Amira
Siemens Medical Solutions USA, Inc.
Radiology
28d
Cleared
Nov 21, 2017
LiverMultiScan
Perspectum Diagnostics, Ltd.
Radiology
76d
Cleared
Nov 17, 2017
Vantage Titan 3T, MRT-3010/A7, M-Power GX
Toshiba Medical Systems Corporation, Japan
Radiology
57d
Cleared
Oct 12, 2017
MAGNETOM Terra
Siemens Medical Solutions USA, Inc.
Radiology
205d
Cleared
Aug 29, 2017
SyMRI
Syntheticmr AB
Radiology
312d
Cleared
Jul 21, 2017
Vantage Elan 1.5T, V4.0
Toshibamedical Systems Corporation
Radiology
51d
Cleared
Jul 19, 2017
Embrace Neonatal MRI System
Aspect Imaging, Ltd.
Radiology
107d
Cleared
Jul 14, 2017
RTHawk, HeartVista Cardiac Package
Heartvista, Inc.
Radiology
185d
Cleared
Jul 14, 2017
SIGNA Premier
Ge Medical Systems, LLC
Radiology
88d
Cleared
Jun 14, 2017
MAGNETOM Vida
Siemens Medical Solutions USA, Inc.
Radiology
125d
Cleared
Jun 07, 2017
Vantage Titan 1.5T, MRT-1510, M-Power GX
Toshibamedical Systems Corporation
Radiology
117d
Cleared
Apr 20, 2017
HyperSense
Ge Medical Systems, LLC
Radiology
203d
Cleared
Apr 10, 2017
Comfort EC710
Alltech Medical Systems America, Inc.
Radiology
146d
Cleared
Mar 17, 2017
Discovery MR750 3.0T
Ge Medical Systems, LLC
Radiology
109d