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
937–960 of 1104
Cleared Jun 15, 1989
MAGNISCAN 5000 MR SYSTEM
K891769
General Electric Co.
Radiology · 83d
Cleared Jun 01, 1989
VERSION 4.2 APPLICATION SOFTWARE
K892959
Resonex, Inc.
Radiology · 38d
Cleared May 11, 1989
MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.
K891541
Diasonics, Inc.
Radiology · 55d
Cleared May 11, 1989
MODEL 2030
K891598
Medical Advances, Inc.
Radiology · 52d
Cleared May 11, 1989
GE SHOULDER SURFACE COIL, CAT. #M1085AN
K892235
General Electric Co.
Radiology · 37d
Cleared May 01, 1989
MODEL 4041
K890855
Medical Advances, Inc.
Radiology · 69d
Cleared Apr 28, 1989
GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K890789
Philips Medical Systems North America, Inc.
Radiology · 72d
Cleared Apr 14, 1989
MODEL 3031
K890666
Medical Advances, Inc.
Radiology · 64d
Cleared Apr 03, 1989
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K890815
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Mar 14, 1989
VISTA MR 2055 HP SYSTEM
K885047
Philips Medical Systems (Cleveland), Inc.
Radiology · 98d
Cleared Mar 14, 1989
MEDRAD SCPD 1000
K890394
Medrad, Inc.
Radiology · 48d
Cleared Feb 02, 1989
ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY
K884816
Diasonics, Inc.
Radiology · 77d
Cleared Jan 24, 1989
MAGNETOM 42 SP AND MAGNETOM 63 SP
K883898
Siemens Medical Solutions USA, Inc.
Radiology · 131d
Cleared Jan 17, 1989
MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
K884484
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Dec 21, 1988
MT/S (SOFTWARE RELEASE 3.1)
K884607
Diasonics, Inc.
Radiology · 47d
Cleared Dec 05, 1988
MT/S (SPINE TRANSMIT COIL)
K884606
Diasonics, Inc.
Radiology · 31d
Cleared Dec 05, 1988
TEMPOROMANDIBULAR JOINT COIL (TMJ)
K884743
Diasonics, Inc.
Radiology · 21d
Cleared Nov 30, 1988
GE MR MAX SYSTEM
K883547
General Electric Co.
Radiology · 103d
Cleared Nov 30, 1988
SHOULDER TRANSMIT AND RECEIVE COILS
K884603
Diasonics, Inc.
Radiology · 27d
Cleared Nov 30, 1988
MT/S CARLSON SPINE COIL, PART # 100-50082500-01
K884604
Diasonics, Inc.
Radiology · 27d
Cleared Nov 28, 1988
POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM
K884369
General Electric Co.
Radiology · 41d
Cleared Nov 23, 1988
MAGNETOM (M, H, 42, 63) SEQUENCES
K884062
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Nov 21, 1988
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL
K883872
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Nov 21, 1988
VISTA MR 2055 HP SYSTEM
K883994
Philips Medical Systems (Cleveland), Inc.
Radiology · 62d