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
49–72 of 1110
Cleared Jan 17, 2025
Prenuvo Body Composition
K242825
Prenuvo
Radiology · 121d
Cleared Jan 07, 2025
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
K243335
Canon Medical Systems Corporation
Radiology · 75d
Cleared Dec 23, 2024
NIDO Baby Magnetic Resonance Imaging System
K242573
Jiangsu Lici Medical Device Co., Ltd.
Radiology · 116d
Cleared Dec 06, 2024
SyMRI
K242524
Syntheticmr AB (Publ.)
Radiology · 105d
Cleared Nov 26, 2024
MROpen Evo (03-2000-00)
K242258
Asg Superconductors S.P.A.
Radiology · 118d
Cleared Oct 17, 2024
SIGNA MAGNUS
K241242
Ge Medical Systems, LLC
Radiology · 167d
Cleared Oct 02, 2024
VitruvianScan (v1.0)
K241925
Perspectum, Ltd.
Radiology · 93d
Cleared Oct 01, 2024
MuscleView
K241331
Springbok, Inc.
Radiology · 144d
Cleared Aug 26, 2024
MyoStrain (6.0)
K241607
Myocardial Solutions, Inc.
Radiology · 83d
Cleared Aug 20, 2024
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
K241496
Canon Medical Systems Corporation
Radiology · 84d
Cleared Aug 13, 2024
ECHELON Synergy MRI System
K241429
Fujifilm Healthcare Corporation
Radiology · 84d
Cleared Jul 22, 2024
neo315
K231133
Neoscan Solution GmbH
Radiology · 458d
Cleared Jul 16, 2024
Swoop® Portable MR Imaging® System
K240944
Hyperfine, Inc.
Radiology · 102d
Cleared Jun 26, 2024
Magnifico Open (100009900)
K241133
Esaote, S.P.A.
Radiology · 63d
Cleared May 10, 2024
APERTO Lucent MRI System
K233629
Fujifilm Healthcare Americas Corporation
Radiology · 179d
Cleared May 03, 2024
ECHELON Synergy V10.0
K233687
Fujifilm Healthcare Americas Corporation
Radiology · 168d
Cleared Apr 26, 2024
uMR Jupiter
K233673
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 162d
Cleared Apr 12, 2024
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
K240238
Canon Medical Systems Corporation
Radiology · 74d
Cleared Apr 12, 2024
OASIS MRI System
K240571
Fujifilm Healthcare Corporation
Radiology · 43d
Cleared Apr 10, 2024
uMR 680
K240744
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 23d
Cleared Mar 29, 2024
MAGNETOM Viato.Mobile
K240608
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Mar 26, 2024
SyMRI
K233733
Syntheticmr AB (Publ.)
Radiology · 126d
Cleared Mar 22, 2024
MAGNETOM Terra
K232322
Siemens Medical Solutions USA, Inc.
Radiology · 232d
Cleared Mar 22, 2024
uMR Omega
K240540
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 25d