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
1009–1032 of 1110
Cleared Aug 03, 1990
LARGE FLEXIBLE BODY COIL
K902314
Toshiba America Mri, Inc.
Radiology · 72d
Cleared Aug 01, 1990
SOFTWARE RELEASE 4.2P, ACCESS(TM)
K902310
Toshiba America Mri, Inc.
Radiology · 70d
Cleared Aug 01, 1990
CERVICAL COIL MRT 50A
K902315
Toshiba America Mri, Inc.
Radiology · 70d
Cleared Aug 01, 1990
KNEE QD COIL MRT 50A
K902316
Toshiba America Mri, Inc.
Radiology · 70d
Cleared Jul 19, 1990
BILATERAL TMJ COIL
K902630
Resonex, Inc.
Radiology · 35d
Cleared Jul 06, 1990
GE SIGNA ADVANTAGE
K901730
GE Medical Systems
Radiology · 81d
Cleared Jun 28, 1990
MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K901980
Summit World Trade Corp.
Radiology · 57d
Cleared May 31, 1990
MODEL 4050-21
K901864
Medical Advances, Inc.
Radiology · 36d
Cleared May 23, 1990
ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63
K901818
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared May 14, 1990
MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS
K900919
Summit World Trade Corp.
Radiology · 83d
Cleared May 14, 1990
MODEL 4050-64
K901639
Medical Advances, Inc.
Radiology · 35d
Cleared May 07, 1990
VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
K901602
Resonex, Inc.
Radiology · 31d
Cleared May 07, 1990
MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI
K901620
Instrumentarium Imaging, Inc.
Radiology · 32d
Cleared Apr 30, 1990
BRUKER R28 WHOLE-BODY MR SCANNER
K900026
Bruker Medical Imaging, Inc.
Radiology · 117d
Cleared Apr 26, 1990
MODEL 2121-64
K901242
Medical Advances, Inc.
Radiology · 42d
Cleared Apr 26, 1990
MODEL 2121-21, TMJ SURFACE COIL
K901305
Medical Advances, Inc.
Radiology · 37d
Cleared Apr 26, 1990
MODEL 6000-21
K901384
Medical Advances, Inc.
Radiology · 31d
Cleared Apr 25, 1990
THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64
K901241
Medical Advances, Inc.
Radiology · 41d
Cleared Apr 05, 1990
MODEL 8010
K901092
Medical Advances, Inc.
Radiology · 29d
Cleared Mar 23, 1990
RADIO FREQUENCY RECEIVER SUBSYSTEM
K900725
Myheal Technologies
Radiology · 36d
Cleared Mar 23, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K900889
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared Mar 19, 1990
MRT 50A SOFTWARE RELEASE 9.0
K900283
Toshiba America Mri, Inc.
Radiology · 56d
Cleared Mar 09, 1990
MAGNETIC RESONANCE SYSTEM MODEL BMT-1100
K895328
Bruker Medical Imaging, Inc.
Radiology · 190d
Cleared Mar 09, 1990
VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM
K900064
Philips Medical Systems (Cleveland), Inc.
Radiology · 64d