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
913–936 of 1104
Cleared Jan 12, 1990
MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC
K896309
Instrumentarium Imaging, Inc.
Radiology · 72d
Cleared Jan 12, 1990
VISTA MR 2055 HP SYSTEM
K896508
Philips Medical Systems (Cleveland), Inc.
Radiology · 58d
Cleared Jan 04, 1990
MODEL 5070
K894855
Medical Advances, Inc.
Radiology · 157d
Cleared Dec 22, 1989
MODEL SPINE SURVEYOR-PLUS
K896336
Medical Advances, Inc.
Radiology · 49d
Cleared Dec 21, 1989
GYROVIEW HR HIGH RESOLUTION WORKSTATION
K896647
Philips Medical Systems North America, Inc.
Radiology · 27d
Cleared Dec 14, 1989
GYROSCAN T5 MOBILE
K895869
Philips Medical Systems, Inc.
Radiology · 71d
Cleared Nov 30, 1989
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
K895966
Siemens Medical Solutions USA, Inc.
Radiology · 50d
Cleared Nov 17, 1989
GE MR MAX SYSTEM
K895794
GE Medical Systems
Radiology · 50d
Cleared Nov 06, 1989
SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
K893744
Shimadzu Medical Systems
Radiology · 172d
Cleared Oct 30, 1989
VISTA MR 2055 HP SYSTEM
K895151
Philips Medical Systems (Cleveland), Inc.
Radiology · 81d
Cleared Oct 27, 1989
MT/S SOFTWARE RELEASE 5.0.
K893518
Diasonics, Inc.
Radiology · 172d
Cleared Oct 27, 1989
MODEL 2031 TMJ SURFACE COIL
K895131
Medical Advances, Inc.
Radiology · 71d
Cleared Oct 03, 1989
ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42
K895221
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Sep 12, 1989
MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM
K894974
Resonex, Inc.
Radiology · 36d
Cleared Sep 07, 1989
ACCESS TM
K894290
Diasonics, Inc.
Radiology · 76d
Cleared Aug 11, 1989
GE SIGNA ADVANTAGE
K893509
GE Medical Systems
Radiology · 98d
Cleared Aug 09, 1989
MRT-50A MOBILE
K893750
Toshiba Medical Systems
Radiology · 83d
Cleared Aug 02, 1989
SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM
K893640
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Jul 20, 1989
VISION INTEGRATED PERFORMANCE OPTION
K893689
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jul 14, 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
K893675
Philips Medical Systems (Cleveland), Inc.
Radiology · 59d
Cleared Jul 14, 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
K893739
Philips Medical Systems (Cleveland), Inc.
Radiology · 58d
Cleared Jun 23, 1989
MAGNAVIEW MOBILE MRI VERSION 110 FHM
K891543
Instrumentarium Imaging, Inc.
Radiology · 98d
Cleared Jun 23, 1989
VISTA MR 2055 HP SYSTEM
K893619
Philips Medical Systems (Cleveland), Inc.
Radiology · 44d
Cleared Jun 23, 1989
ACCESS TM
K893881
Diasonics, Inc.
Radiology · 28d