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..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
217–240 of 1101
Cleared Oct 12, 2018
MAGNETOM Sola
K182129
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Oct 05, 2018
MAGNETOM Sola
K181322
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Oct 03, 2018
uMR 780
K181370
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 133d
Cleared Oct 03, 2018
uMR 790
K181371
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 133d
Cleared Aug 13, 2018
Vantage Galan 3T, MRT-3020/A7, V5.0
K181593
Canon Medical Systems Corporation
Radiology · 56d
Cleared Aug 03, 2018
Ingenia Ambition S and Ingenia Ambition X
K181479
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Jun 15, 2018
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
K173507
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 214d
Cleared Jun 14, 2018
MRIaudio PREM System
K180100
Mriaudio
Radiology · 149d
Cleared Jun 12, 2018
SyMRI
K181093
Syntheticmr AB
Radiology · 48d
Cleared Jun 06, 2018
uMR 570
K180925
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 58d
Cleared Jun 06, 2018
uMR 560
K180926
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
K173079
Philips Medical Systems Nederland B.V.
Radiology · 187d
Cleared Mar 30, 2018
MAGNETOM Vida with Compressed Sensing GRASP-VIBE
K173617
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Mar 30, 2018
G-scan Brio
K180592
Esaote, S.P.A.
Radiology · 24d
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