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
457–480 of 1110
Cleared Nov 17, 2005
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009
GE Medical Systems
Radiology · 22d
Cleared Nov 09, 2005
GE 1.5T SIGNA HDE MR SYSTEM
K052978
Ge Medical Systems, LLC
Radiology · 16d
Cleared Nov 08, 2005
MODIFICATION TO: AURORA
K052698
Aurora Imaging Technology, Inc.
Radiology · 41d
Cleared Nov 08, 2005
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
K052987
Noras Rontgen-Und Medizintechnik GmbH
Radiology · 15d
Cleared Oct 17, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
K052571
Neurognostics, Inc.
Radiology · 28d
Cleared Oct 04, 2005
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
K052164
Siemens Medical Solutions USA, Inc.
Radiology · 56d
Cleared Sep 27, 2005
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
K052172
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared Sep 27, 2005
PORTAL GRAVITY SYSTEM
K052579
Portal, Inc.
Radiology · 7d
Cleared Sep 22, 2005
SIMTEC IM-MAXX 2 OPTION
K052315
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Sep 21, 2005
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
K052293
Ge Medical Systems, LLC
Radiology · 29d
Cleared Sep 08, 2005
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
K052305
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Sep 07, 2005
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
K052078
Philips Medical Systems Nederland B.V.
Radiology · 37d
Cleared Aug 02, 2005
ACHIEVA 1.5T & INERA 1.5T FAMILY
K052013
Philips Medical Systems Nederland B.V.
Radiology · 7d
Cleared Apr 07, 2005
ALTAIRE
K050602
Hitachi Medical Systems America, Inc.
Radiology · 29d
Cleared Mar 18, 2005
STARSHIELD V3 RF TRNT
K050237
Odin Medical Technologies , Ltd.
Radiology · 44d
Cleared Feb 28, 2005
MAGNETOM TRIO A TIM SYSTEM
K050200
Siemens Medical Solutions USA, Inc.
Radiology · 31d
Cleared Feb 18, 2005
MAGNETOM SYMPHONY A TIM SYSTEM
K050199
Siemens Medical Solution
Radiology · 21d
Cleared Feb 15, 2005
ACHIEVA FAMILY
K043147
Philips Medical Systems North America Co.
Radiology · 92d
Cleared Feb 15, 2005
NEURO II-S
K050132
Innovative Magnetic Resonance Imaging Systems, Inc.
Radiology · 25d
Cleared Jan 28, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
K043290
Neurognostics, Inc.
Radiology · 60d
Cleared Jan 21, 2005
R2-MRI ANALYSIS SYSTEM
K043271
Inner Vision Biometrics Pty, Ltd.
Radiology · 56d
Cleared Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262
Ge Healthcare
Radiology · 49d
Cleared Dec 09, 2004
MAGNETOM C! MR SYSTEM
K043030
Siemens Medical Solutions
Radiology · 36d
Cleared Nov 24, 2004
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
K043112
General Electric Co.
Radiology · 14d