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
769–792 of 1101
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 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
VISTA MR 2055 HP SYSTEM
K893619
Philips Medical Systems (Cleveland), Inc.
Radiology · 44d
Cleared Jun 23, 1989
ACCESS TM
K893881
Diasonics, Inc.
Radiology · 28d
Cleared Jun 15, 1989
MAGNISCAN 5000 MR SYSTEM
K891769
General Electric Co.
Radiology · 83d
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