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..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
97–120 of 1101
Cleared Dec 23, 2022
MR 5300 and MR 7700 R11 MR Systems
K223442
Philips Medical Systems Nederlands B.V.
Radiology · 39d
Cleared Dec 06, 2022
Swoop Portable MR Imaging System
K223247
Hyperfine, Inc.
Radiology · 46d
Cleared Oct 28, 2022
Stage
K223079
Spintech, 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 Sep 06, 2022
LiverMultiScan v5 (LMSv5)
K213960
Perspectum
Radiology · 263d
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 Aug 29, 2022
TCL3 Motion Tracking System
K221785
Tracinnovations A/S
Radiology · 69d
Cleared Jul 28, 2022
Swoop Portable MR Imaging System
K221923
Hyperfine, Inc.
Radiology · 27d
Cleared Jul 12, 2022
Veuron-Brain-mN1
K203279
Heuron Co., Ltd.
Radiology · 613d
Cleared Jul 01, 2022
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
K221025
Mri Division,Beijing Wandong Medical Technology Co., Ltd.
Radiology · 86d
Cleared Jun 24, 2022
MAGNETOM Free.Max, MAGNETOM Free.Star
K220575
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared Jun 10, 2022
Swoop Portable MR Imaging System
K221393
Hyperfine, Inc.
Radiology · 28d
Cleared Jun 08, 2022
AIR Recon DL
K213717
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 196d
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