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 Canon Medical Systems Corporation, Siemens Medical Solutions USA, Inc. and Shanghai United Imaging Healthcare Co., Ltd..

1098
Total
1098
Cleared
110d
Avg days
1988
Since
1098 devices
49–72 of 1098
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
Cleared Feb 29, 2024
MAGNETOM Cima.X Fit
K232765
Siemens Medical Solutions USA, Inc.
Radiology · 174d
Cleared Feb 15, 2024
InVision™ 1.5 Surgical Theatre
K240157
Deerfield Imaging, Inc.
Radiology · 27d
Cleared Feb 08, 2024
neuro42 MRI System
K232644
Neuro42, Inc.
Radiology · 162d
Cleared Jan 19, 2024
SIGNA Champion
K233728
Ge Healthcare (Tianjin) Company Limited
Radiology · 59d
Cleared Dec 22, 2023
MAGNETOM Sola
K232535
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Dec 18, 2023
MAGNETOM Cima.X
K231587
Siemens Medical Solutions USA, Inc.
Radiology · 201d
Cleared Nov 14, 2023
MAGNETOM Avanto fit
K232494
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 09, 2023
MAGNETOM Free.Max
K231617
Siemens Medical Solutions USA, Inc.
Radiology · 160d
Cleared Oct 27, 2023
Digital Expert Access with Remote Scanning
K232346
Ge Healthcare
Radiology · 84d
Cleared Oct 23, 2023
MAGNETOM Vida
K231560
Siemens Medical Solutions USA, Inc.
Radiology · 146d
Cleared Oct 06, 2023
Swoop® Portable MR Imaging System®
K232760
Hyperfine, Inc.
Radiology · 28d
Cleared Sep 06, 2023
MAGNETOM Viato.Mobile
K232482
Siemens Medical Solutions USA, Inc.
Radiology · 21d