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
145–168 of 1101
Cleared Mar 31, 2021
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
K203443
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Mar 10, 2021
Vantage Elan 1.5T, MRT-2020, V6.0
K210164
Canon Medical Systems Corporation
Radiology · 48d
Cleared Mar 04, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K203323
Canon Medical Systems Corporation
Radiology · 112d
Cleared Mar 03, 2021
Promaxo MRI System
K202518
Promaxo, Inc.
Radiology · 183d
Cleared Mar 02, 2021
MRI PPG Patient Cable
K203653
Ivy Biomedical Systems, Inc.
Radiology · 77d
Cleared Feb 02, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K203553
Canon Medical Systems Corporation
Radiology · 60d
Cleared Jan 29, 2021
i_Space 1.5T Superconducting Magnetic Resonance Imaging System
K192650
Mri Division,Beijing Wandong Medical Technology Co., Ltd.
Radiology · 493d
Cleared Jan 15, 2021
Vantage Orian 1.5T, MRT-1550, V6.0
K202767
Canon Medical Systems Corporation
Radiology · 116d
Cleared Jan 12, 2021
Hepatica v1 (Hepatica v1.0.0)
K203280
Perspectum, Ltd.
Radiology · 67d
Cleared Dec 07, 2020
HepaFat-AI
K201039
Resonance Health Analysis Services Pty, Ltd.
Radiology · 231d
Cleared Dec 02, 2020
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
K203053
Canon Medical Systems Corporation
Radiology · 56d
Cleared Nov 13, 2020
SIGNA Architect
K202966
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 44d
Cleared Oct 21, 2020
OASIS MRI System
K202030
Hitachi Healthcare Americas
Radiology · 91d
Cleared Oct 15, 2020
SIGNA 7.0T
K201615
Ge Medical Systems, LLC
Radiology · 122d
Cleared Oct 02, 2020
LiverMultiScan
K202170
Perspectum, Ltd.
Radiology · 60d
Cleared Sep 22, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
K202210
Canon Medical Systems Corporation
Radiology · 47d
Cleared Sep 08, 2020
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit
K202014
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Sep 04, 2020
SIGNA Artist
K202238
Ge Healthcare (Tianjin) Company Limited
Radiology · 28d
Cleared Aug 26, 2020
FIRMM
K201141
Nous Imaging, Inc.
Radiology · 119d
Cleared Aug 11, 2020
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K201722
Hyperfine Research, Inc.
Radiology · 49d
Cleared Jul 28, 2020
SyMRI
K201616
Syntheticmr AB
Radiology · 43d
Cleared Jul 14, 2020
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
K193097
Canon Medical Systems Corporation
Radiology · 250d
Cleared Jul 10, 2020
Resoundant Acoustic Driver System
K201389
Resoundant, Inc.
Radiology · 44d
Cleared Jul 06, 2020
uMR570
K201540
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 27d