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
Nov 22, 2016
MAGNETOM Avantofit, MAGNETOM Skyrafit
Siemens Medi Cal Solutions, Inc.
Radiology
116d
Cleared
Nov 18, 2016
MAGNETOM ESSENZA
Siemens Medical Solutions USA, Inc.
Radiology
141d
Cleared
Nov 18, 2016
HyperBand
Ge Medical Systems, LLC
Radiology
81d
Cleared
Oct 25, 2016
G-scan Brio, S-scan
Esaote, S.P.A.
Radiology
99d
Cleared
Sep 01, 2016
SIGNA Voyager
Ge Healthcare
Radiology
86d
Cleared
Aug 31, 2016
MAGiC
Ge Medical Systems, LLC
Radiology
104d
Cleared
Aug 23, 2016
Vantage Titan 1.5T, MRT-1510, V3.6 Software
Toshibamedical Systems Corporation
Radiology
169d
Cleared
Jul 08, 2016
S-scan
Esaote, S.P.A.
Radiology
67d
Cleared
Jun 30, 2016
RTHawk, HeartVista Cardiac Package
Heartvista, Inc.
Radiology
185d
Cleared
Jun 09, 2016
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
Ge Medical Systems, LLC
Radiology
98d
Cleared
May 20, 2016
Trillium Oval V 5.1 MRI System
Hitachi Medical Systems America, Inc.
Radiology
119d
Cleared
Apr 15, 2016
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
Siemens Medi Cal Solutions, Inc.
Radiology
148d
Cleared
Mar 31, 2016
MAGNETOM Spectra
Siemens Medical Solutions USA, Inc.
Radiology
125d
Cleared
Mar 31, 2016
ECHELON Oval V 5.1 MRI System
Hitachi Medical Systems America, Inc.
Radiology
111d
Cleared
Mar 29, 2016
SIGNAPioneer
Ge Healthcare
Radiology
25d
Cleared
Mar 22, 2016
Ingenia 1.5T and Ingenia 1.5T S R5.2
Philips Medical Systems Nederlands B.V.
Radiology
125d
Cleared
Mar 01, 2016
Wrist 3
Aspect Imaging, Ltd.
Radiology
34d
Cleared
Jan 08, 2016
MRI Dynamic Analysis Plus
Esaote, S.P.A.
Radiology
81d
Cleared
Dec 24, 2015
MAGNETOM Amira
Siemens Medical Solutions USA, Inc.
Radiology
134d
Cleared
Dec 22, 2015
Magnetic Reasonance Imaging System
Jiangsu Magspin Instrument Co.,Ltd
Radiology
244d
Cleared
Oct 27, 2015
SIGNA Pioneer
Ge Healthcare
Radiology
14d
Cleared
Oct 23, 2015
Vantage Titan 3T
Toshibamedical Systems Corporation
Radiology
63d
Cleared
Oct 15, 2015
MrOpen
Paramed S.R.L.
Radiology
136d
Cleared
Sep 29, 2015
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
Siemens Medical Solutions USA, Inc.
Radiology
110d