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..

1110
Total
1110
Cleared
110d
Avg days
1988
Since
1110 devices
241–264 of 1110
Cleared Mar 20, 2018
Ingenia Elition S and Ingenia Elition X
K173451
Philips Medical Systems Nederland B.V.
Radiology · 134d
Cleared Mar 14, 2018
MR Wireless Gating System, Model WGS-100
K171778
Ivy Biomedical Systems, Inc.
Radiology · 272d
Cleared Mar 06, 2018
Ingenia Elition S and Ingenia Elition X R5.4
K173356
Philips Medical Systems Nederland B.V.
Radiology · 132d
Cleared Feb 23, 2018
SPIN-SWI
K173224
Spintech, Inc.
Radiology · 143d
Cleared Feb 16, 2018
Wireless Audio System
K173409
Neocoil, LLC
Radiology · 107d
Cleared Feb 13, 2018
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
K173592
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jan 26, 2018
Vantage Galan 3T, V4.6
K173382
Toshibamedical Systems Corporation
Radiology · 88d
Cleared Jan 26, 2018
SyMRI
K173558
Syntheticmr AB
Radiology · 70d
Cleared Jan 22, 2018
3D APT
K172920
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Jan 11, 2018
ECHELON OVAL V6.0A MRI System
K172110
Hitachi Healthcare Americas Corporation
Radiology · 182d
Cleared Dec 19, 2017
MAGNETOM Amira
K173600
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Nov 21, 2017
LiverMultiScan
K172685
Perspectum Diagnostics, Ltd.
Radiology · 76d
Cleared Nov 17, 2017
Vantage Titan 3T, MRT-3010/A7, M-Power GX
K172878
Toshiba Medical Systems Corporation, Japan
Radiology · 57d
Cleared Oct 12, 2017
MAGNETOM Terra
K170840
Siemens Medical Solutions USA, Inc.
Radiology · 205d
Cleared Aug 29, 2017
SyMRI
K162943
Syntheticmr AB
Radiology · 312d
Cleared Jul 21, 2017
Vantage Elan 1.5T, V4.0
K171597
Toshibamedical Systems Corporation
Radiology · 51d
Cleared Jul 19, 2017
Embrace Neonatal MRI System
K170978
Aspect Imaging, Ltd.
Radiology · 107d
Cleared Jul 14, 2017
RTHawk, HeartVista Cardiac Package
K170090
Heartvista, Inc.
Radiology · 185d
Cleared Jul 14, 2017
SIGNA Premier
K171128
Ge Medical Systems, LLC
Radiology · 88d
Cleared Jun 14, 2017
MAGNETOM Vida
K170396
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Jun 07, 2017
Vantage Titan 1.5T, MRT-1510, M-Power GX
K170412
Toshibamedical Systems Corporation
Radiology · 117d
Cleared Apr 20, 2017
HyperSense
K162722
Ge Medical Systems, LLC
Radiology · 203d
Cleared Apr 10, 2017
Comfort EC710
K163192
Alltech Medical Systems America, Inc.
Radiology · 146d
Cleared Mar 17, 2017
Discovery MR750 3.0T
K163331
Ge Medical Systems, LLC
Radiology · 109d