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..

1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
73–96 of 1104
Cleared Dec 13, 2023
fMRI Hardware System
K232680
Nordicneurolab AS
Radiology · 103d
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 11, 2023
Synq Software Version 1.3
K232981
Synaptive Medical, Inc.
Radiology · 20d
Cleared Oct 06, 2023
Swoop® Portable MR Imaging System®
K232760
Hyperfine, Inc.
Radiology · 28d
Cleared Sep 29, 2023
Terran NM-101
K230187
Terran Biosciences, Inc.
Radiology · 249d
Cleared Sep 06, 2023
MAGNETOM Viato.Mobile
K232482
Siemens Medical Solutions USA, Inc.
Radiology · 21d
Cleared Sep 05, 2023
Promaxo MRI System II
K232361
Promaxo, Inc.
Radiology · 29d
Cleared Aug 30, 2023
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
K230355
Canon Medical Systems Corporation
Radiology · 202d
Cleared Aug 02, 2023
Ingenia Elition R5.7.1 SP4 MR Systems
K232030
Philips Medical Systems Nederland B.V.
Radiology · 26d
Cleared Jul 13, 2023
ECHELON Synergy MRI system
K223426
Fujifilm Healthcare Corporation
Radiology · 241d
Cleared Jun 20, 2023
HepaFatSmart (V2.0.0)
K231459
Resonance Health Analysis Services Pty, Ltd.
Radiology · 32d
Cleared May 30, 2023
Sonic DL
K223523
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 188d
Cleared May 23, 2023
uMR Omega
K230152
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 124d
Cleared May 18, 2023
uMR 570
K230758
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 59d
Cleared Apr 28, 2023
Ingenia Elition and MR 7700 MR Systems
K230972
Philips Medical Systems Nederland B.V.
Radiology · 23d
Cleared Apr 06, 2023
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
K223458
Philips Medical Systems Nederland B.V.
Radiology · 141d
Cleared Mar 28, 2023
MAGNETOM Amira
K223343
Siemens Medical Solutions USA, Inc.
Radiology · 147d
Cleared Mar 20, 2023
MOBINEURO Alita Intraoperative MRI System
K223875
Sino Canada Health Engineering Research Institute (Hefei)
Radiology · 87d
Cleared Mar 02, 2023
1.5T 24E Posterior Array
K223203
Shenzhen RF Tech Co., Ltd.
Radiology · 139d
Cleared Feb 24, 2023
MAGNETOM Vida
K213805
Siemens Medical Solutions USA, Inc.
Radiology · 445d
Cleared Feb 22, 2023
Swoop® Portable MR Imaging System™
K230208
Hyperfine, Inc.
Radiology · 28d