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..

1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
481–504 of 1104
Cleared Feb 12, 2002
E-SCAN XQ
K020164
Biosound Esaote, Inc.
Radiology · 26d
Cleared Jan 24, 2002
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
K013636
GE Medical Systems
Radiology · 80d
Cleared Jan 22, 2002
INFINION 0.6T MR IMAGING SYSTEM
K013858
Philips Medical Systems (Cleveland), Inc.
Radiology · 62d
Cleared Dec 28, 2001
MAGNETOM TRIO SYSTEM
K013586
Siemens Medical Systems, Inc.
Radiology · 59d
Cleared Dec 11, 2001
INTERA I/T
K013344
Philips Medical Systems North America Co.
Radiology · 63d
Cleared Nov 20, 2001
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
K012875
GE Medical Systems
Radiology · 85d
Cleared Oct 31, 2001
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
K012495
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Sep 24, 2001
GE SIGNA ASSET IMAGING OPTION
K012970
GE Medical Systems
Radiology · 20d
Cleared Aug 03, 2001
1.5T INFINITY TWINSPEED MR SYSTEM
K012200
GE Medical Systems
Radiology · 21d
Cleared Jul 19, 2001
INFINION ENHANCEMENT PACKAGE
K011296
Philips Medical Systems (Cleveland), Inc.
Radiology · 80d
Cleared May 30, 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared May 08, 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
K010691
Philips Medical Systems (Cleveland), Inc.
Radiology · 61d
Cleared Apr 11, 2001
FIESTA IMAGING OPTION
K002997
GE Medical Systems
Radiology · 197d
Cleared Apr 09, 2001
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
K010570
Mri Devices Corp.
Radiology · 42d
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 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 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 Oct 31, 2000
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
K002611
GE Medical Systems
Radiology · 70d