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
1081–1104 of 1110
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 17, 1989
RMI SHORT DISTANCE ALIGNMENT DEVICE
K885223
Radiation Measurements, Inc.
Radiology · 59d
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
Cleared Nov 14, 1988
TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM
K883756
Toshiba Medical Systems
Radiology · 69d
Cleared Nov 10, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
K883621
Instrumentarium Corp.
Radiology · 77d
Cleared Oct 31, 1988
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
K883699
Fonar Corp.
Radiology · 62d
Cleared Oct 19, 1988
VISTA MR 2055 HP SYSTEM
K883482
Philips Medical Systems (Cleveland), Inc.
Radiology · 64d
Cleared Oct 19, 1988
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)
K883519
Philips Medical Systems (Cleveland), Inc.
Radiology · 62d
Cleared Oct 19, 1988
BETA 3000M MOBILE NMR IMAGING SYSTEM
K883648
Fonar Corp.
Radiology · 50d
Cleared Oct 19, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
K883649
Instrumentarium Corp.
Radiology · 51d
Cleared Oct 13, 1988
VFQ HEAD COIL
K883737
Resonex, Inc.
Radiology · 42d