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
553–576 of 1110
Cleared Mar 15, 2001
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
K003899
Mri Devices Corp.
Radiology · 87d
Cleared Mar 13, 2001
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
K003947
GE Medical Systems
Radiology · 82d
Cleared Feb 21, 2001
AURORA
K003651
Aurora Imaging Technology, Inc.
Radiology · 86d
Cleared Feb 13, 2001
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
K003853
Philips Medical Systems (Cleveland), Inc.
Radiology · 63d
Cleared Feb 02, 2001
MODIFICATION TO ARTOSCAN M
K010057
Biosound Esaote, Inc.
Radiology · 25d
Cleared Jan 23, 2001
DIFFUSION TENSOR IMAGING OPTION
K003573
Ge Medical Systems, Inc.
Radiology · 64d
Cleared Jan 23, 2001
MAGNETOM RHAPSODY SYSTEM
K003628
Siemens Medical Solutions USA, Inc.
Radiology · 60d
Cleared Jan 18, 2001
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS
K003453
Fonar Corp.
Radiology · 72d
Cleared Dec 27, 2000
GYROSCAN INTERA 3.0T
K003516
Philips Medical Systems North America, Inc.
Radiology · 43d
Cleared Dec 21, 2000
MAGNETIC CONCERTO
K003192
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Dec 21, 2000
INTERACTIVE REAL TIME SCANNING PACKAGE
K003623
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 19, 2000
NEURO II
K002964
Innovative Magnetic Resonance Imaging Systems, Inc.
Radiology · 88d
Cleared Oct 31, 2000
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
K002611
GE Medical Systems
Radiology · 70d
Cleared Oct 26, 2000
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
K002531
Toshiba America Mri, Inc.
Radiology · 71d
Cleared Oct 17, 2000
HITACHI ALTAIRE
K002420
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Oct 11, 2000
MAGNETOM ALLEGRA SYSTEM
K002179
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Oct 03, 2000
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
K002490
Fonar Corp.
Radiology · 50d
Cleared Sep 20, 2000
POLESTAR N-10
K002242
Odin Technologies , Ltd.
Radiology · 58d
Cleared Sep 06, 2000
GYROSCAN INTERA (R7.5)
K001796
Philips Medical Systems North America, Inc.
Radiology · 84d
Cleared Sep 06, 2000
EXPLORER GRADIENT
K001987
Philips Medical Systems North America, Inc.
Radiology · 69d
Cleared Aug 30, 2000
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
K994283
Medis Medical Imaging Systems BV
Radiology · 254d
Cleared Aug 18, 2000
ORTHONE
K001773
Oni, Inc.
Radiology · 67d
Cleared Aug 18, 2000
POWERDRIVE 350 OPTION
K002415
Philips Medical Systems (Cleveland), Inc.
Radiology · 10d
Cleared Aug 08, 2000
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
K002225
Siemens Medical Solutions USA, Inc.
Radiology · 15d