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..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
385–408 of 1101
Cleared May 13, 2003
ADVANTAGE WORKSTATION PASTING 1.1
K031396
GE Medical Systems
Radiology · 11d
Cleared May 02, 2003
GE PROPELLER IMAGING OPTION FOR MRI
K031230
GE Medical Systems
Radiology · 14d
Cleared Mar 28, 2003
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
K030874
General Electric Co.
Radiology · 8d
Cleared Feb 04, 2003
PANORAMA ENHANCEMENTS
K024042
Philips Medical Systems, Inc.
Radiology · 60d
Cleared Feb 04, 2003
INFINION SOFTWARE FEATURES
K024066
Philips Medical Systems (Cleveland), Inc.
Radiology · 57d
Cleared Nov 05, 2002
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
K023511
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Oct 11, 2002
HITACHI ALTAIRE
K022390
Hitachi Medical Systems America, Inc.
Radiology · 80d
Cleared Oct 11, 2002
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
K023130
Mri Devices Corp.
Radiology · 21d
Cleared Oct 09, 2002
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
K023207
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Aug 22, 2002
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
K022397
GE Medical Systems
Radiology · 30d
Cleared Jun 13, 2002
SYNGO MR 2002B
K020991
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Mar 13, 2002
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
K020573
Siemens Medical Solutions USA, Inc.
Radiology · 44d
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 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