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..
1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
Cleared
Oct 12, 2018
MAGNETOM Sola
Siemens Medical Solutions USA, Inc.
Radiology
67d
Cleared
Oct 05, 2018
MAGNETOM Sola
Siemens Medical Solutions USA, Inc.
Radiology
140d
Cleared
Oct 03, 2018
uMR 780
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
133d
Cleared
Oct 03, 2018
uMR 790
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
133d
Cleared
Aug 13, 2018
Vantage Galan 3T, MRT-3020/A7, V5.0
Canon Medical Systems Corporation
Radiology
56d
Cleared
Aug 03, 2018
Ingenia Ambition S and Ingenia Ambition X
Philips Medical Systems Nederland B.V.
Radiology
59d
Cleared
Jun 15, 2018
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
Philips Healthcare (Suzhou) Co., Ltd.
Radiology
214d
Cleared
Jun 14, 2018
MRIaudio PREM System
Mriaudio
Radiology
149d
Cleared
Jun 12, 2018
SyMRI
Syntheticmr AB
Radiology
48d
Cleared
Jun 06, 2018
uMR 570
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
58d
Cleared
Jun 06, 2018
uMR 560
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
58d
Cleared
Apr 04, 2018
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
Philips Medical Systems Nederland B.V.
Radiology
187d
Cleared
Mar 30, 2018
MAGNETOM Vida with Compressed Sensing GRASP-VIBE
Siemens Medical Solutions USA, Inc.
Radiology
128d
Cleared
Mar 30, 2018
G-scan Brio
Esaote, S.P.A.
Radiology
24d
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