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
Jan 27, 2017
MAGNETOM Sempra with syngo MR E11S
Siemens Medical Solutions USA, Inc.
Radiology
72d
Cleared
Jan 27, 2017
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
Siemens Medical Solutions USA, Inc.
Radiology
65d
Cleared
Jan 06, 2017
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
Philips Medical Systems Nederland B.V.
Radiology
79d
Cleared
Jan 06, 2017
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
Philips Medical Systems Nederland B.V.
Radiology
60d
Cleared
Dec 30, 2016
MultiBand SENSE
Philips Medical Systems Nederland B.V.
Radiology
70d
Cleared
Nov 25, 2016
Vantage Galan 3T, MRT-3020, V4.0
Toshibamedical Systems Corporation
Radiology
113d
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