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
265–288 of 1110
Cleared Jan 27, 2017
MAGNETOM Sempra with syngo MR E11S
K163211
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Jan 27, 2017
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
K163312
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jan 06, 2017
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
K162931
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
K163116
Philips Medical Systems Nederland B.V.
Radiology · 60d
Cleared Dec 30, 2016
MultiBand SENSE
K162940
Philips Medical Systems Nederland B.V.
Radiology · 70d
Cleared Nov 25, 2016
Vantage Galan 3T, MRT-3020, V4.0
K162183
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Nov 22, 2016
MAGNETOM Avantofit, MAGNETOM Skyrafit
K162102
Siemens Medi Cal Solutions, Inc.
Radiology · 116d
Cleared Nov 18, 2016
MAGNETOM ESSENZA
K161795
Siemens Medical Solutions USA, Inc.
Radiology · 141d
Cleared Nov 18, 2016
HyperBand
K162403
Ge Medical Systems, LLC
Radiology · 81d
Cleared Oct 25, 2016
G-scan Brio, S-scan
K161973
Esaote, S.P.A.
Radiology · 99d
Cleared Sep 01, 2016
SIGNA Voyager
K161567
Ge Healthcare
Radiology · 86d
Cleared Aug 31, 2016
MAGiC
K161397
Ge Medical Systems, LLC
Radiology · 104d
Cleared Aug 23, 2016
Vantage Titan 1.5T, MRT-1510, V3.6 Software
K160632
Toshibamedical Systems Corporation
Radiology · 169d
Cleared Jul 08, 2016
S-scan
K161238
Esaote, S.P.A.
Radiology · 67d
Cleared Jun 30, 2016
RTHawk, HeartVista Cardiac Package
K153740
Heartvista, Inc.
Radiology · 185d
Cleared Jun 09, 2016
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
K160618
Ge Medical Systems, LLC
Radiology · 98d
Cleared May 20, 2016
Trillium Oval V 5.1 MRI System
K160152
Hitachi Medical Systems America, Inc.
Radiology · 119d
Cleared Apr 15, 2016
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
K153343
Siemens Medi Cal Solutions, Inc.
Radiology · 148d
Cleared Mar 31, 2016
MAGNETOM Spectra
K153447
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Mar 31, 2016
ECHELON Oval V 5.1 MRI System
K153547
Hitachi Medical Systems America, Inc.
Radiology · 111d
Cleared Mar 29, 2016
SIGNAPioneer
K160621
Ge Healthcare
Radiology · 25d
Cleared Mar 22, 2016
Ingenia 1.5T and Ingenia 1.5T S R5.2
K153324
Philips Medical Systems Nederlands B.V.
Radiology · 125d
Cleared Mar 01, 2016
Wrist 3
K160185
Aspect Imaging, Ltd.
Radiology · 34d
Cleared Jan 08, 2016
MRI Dynamic Analysis Plus
K153039
Esaote, S.P.A.
Radiology · 81d