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
529–552 of 1110
Cleared Mar 13, 2002
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
K020573
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Feb 12, 2002
E-SCAN XQ
K020164
Biosound Esaote, Inc.
Radiology · 26d
Cleared Feb 05, 2002
CANVAS N-VAS-D 2.0
K014011
Vassol, Inc.
Radiology · 62d
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 17, 2001
POLESTAR N-10
K010850
Odin Medical Technologies , Ltd.
Radiology · 271d
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 Oct 18, 2001
MR-GUIDE 2000
K013150
Ultraguide , Ltd.
Radiology · 28d
Cleared Sep 27, 2001
NUMARIS 4VA15A
K012202
Siemens Medical Corp.
Radiology · 76d
Cleared Sep 24, 2001
GE SIGNA ASSET IMAGING OPTION
K012970
GE Medical Systems
Radiology · 20d
Cleared Sep 19, 2001
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K012154
Aurora Imaging Technology, Inc.
Radiology · 70d
Cleared Aug 06, 2001
MUSCLE IMAGING SYSTEM (MIS)
K011416
Millennium Magnetic Imaging, Inc.
Radiology · 90d
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 Jun 06, 2001
QED DIODE DETECTORS, MODELS 1112-1116
K011466
Sun Nuclear Corp.
Radiology · 23d
Cleared Jun 06, 2001
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
K011485
Fonar Corp.
Radiology · 22d
Cleared May 30, 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared May 24, 2001
ULTRAGUIDE MR-GUIDE 3000
K011418
Ultraguide , Ltd.
Radiology · 15d
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