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