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
577–600 of 1110
Cleared Jul 06, 2000
HITACHI AIRIS II
K001334
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Jul 06, 2000
MODIFICATION TO E-SCAN
K001894
Biosound Esaote, Inc.
Radiology · 15d
Cleared May 26, 2000
SPIRAL IMAGING OPTION
K000802
GE Medical Systems
Radiology · 74d
Cleared Apr 27, 2000
STEROTACTIC LOCALIZATION DEVICE (SLD)
K000832
Philips Medical Systems North America, Inc.
Radiology · 44d
Cleared Mar 27, 2000
VENTRICULAR ANALYSIS TOOLKIT OPTION
K000315
GE Medical Systems
Radiology · 55d
Cleared Mar 22, 2000
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
K994351
Resonance Technology, Inc.
Radiology · 90d
Cleared Mar 16, 2000
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
K994287
Fonar Corp.
Radiology · 87d
Cleared Mar 02, 2000
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
K994282
Medis Medical Imaging Systems BV
Radiology · 73d
Cleared Feb 06, 2000
EXCELART WITH PIANISSIMO
K993803
Toshiba America Mri, Inc.
Radiology · 89d
Cleared Feb 04, 2000
MR ENHANCER
K994117
I.Z.I. Corp.
Radiology · 60d
Cleared Jan 20, 2000
MRI EQUIPMENT COVER
K993682
Image-Guided Neurologics, Inc.
Radiology · 80d
Cleared Jan 18, 2000
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
K993574
Toshiba America Mri, Inc.
Radiology · 89d
Cleared Jan 14, 2000
MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
K994316
Siemens Medical Corp.
Radiology · 23d
Cleared Dec 23, 1999
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K993731
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Dec 07, 1999
PHILIPS EASYVISION WORKSTATION
K990329
Philips Medical Systems North America, Inc.
Radiology · 308d
Cleared Nov 09, 1999
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
K992746
Ge Medical Systems, Inc.
Radiology · 85d
Cleared Nov 01, 1999
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
K990826
Siemens Medical Solutions USA, Inc.
Radiology · 234d
Cleared Oct 18, 1999
PHILIPS GYROSCAN INTERA (*)
K992533
Philips Medical Systems North America, Inc.
Radiology · 81d
Cleared Oct 08, 1999
VIRGO MRI SYSTEM
K990153
Millennium Technology Services
Radiology · 262d
Cleared Oct 05, 1999
PREFERENCE TREATMENT SYSTEM
K983793
Northwest Medical Physics Equipment, Inc.
Radiology · 343d
Cleared Sep 16, 1999
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
K992892
Magnetic Moments, LLC
Radiology · 20d
Cleared Sep 09, 1999
PHILIPS EASYVISION WORKSTATION:
K990335
Philips Medical Systems North America, Inc.
Radiology · 218d
Cleared Sep 08, 1999
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
K992135
Ge Medical Systems, Inc.
Radiology · 76d
Cleared Sep 07, 1999
QUANTITATIVE FLOW
K992225
Philips Medical Systems (Cleveland), Inc.
Radiology · 67d