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
97–120 of 1110
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
Cleared Feb 21, 2023
NEONA 1.5T MRI System
K222259
Time Medical Limited
Radiology · 208d
Cleared Feb 16, 2023
uMR 680
K222755
Shanghai United Imaging Intelligence Co., Ltd.
Radiology · 157d
Cleared Feb 13, 2023
SIGNA Victor
K223439
Ge Healthcare (Tianjin) Company Limited
Radiology · 91d
Cleared Jan 26, 2023
ECHELON Oval V6.2 MRI System
K221619
Fujifilm Healthcare Corporation
Radiology · 237d
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