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
73–96 of 1098
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 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 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
Cleared Oct 27, 2022
uMR Omega with uWS-MR-MRS
K220332
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 265d
Cleared Oct 25, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
K222968
Canon Medical Systems Corporation
Radiology · 28d
Cleared Sep 13, 2022
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
K221733
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Aug 31, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K222387
Canon Medical Systems Corporation
Radiology · 23d
Cleared Jun 24, 2022
MAGNETOM Free.Max, MAGNETOM Free.Star
K220575
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared May 16, 2022
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
K213583
Philips Medical Systems Nederland B.V.
Radiology · 185d
Cleared May 13, 2022
MAGNETOM Skyra Fit
K220589
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared Apr 29, 2022
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
K220939
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Apr 08, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K220192
Canon Medical Systems Corporation
Radiology · 74d
Cleared Apr 05, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
K220335
Canon Medical Systems Corporation
Radiology · 57d
Cleared Apr 01, 2022
MAGNETOM Avanto Fit
K220151
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Mar 11, 2022
MAGNETOM Vida, MAGNETOM Sola
K220425
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Mar 03, 2022
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
K213516
Philips Medical Systems Nederland B.V.
Radiology · 120d
Cleared Mar 03, 2022
MR Elastography
K220018
Canon Medical Systems Corporation
Radiology · 57d