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
697–720 of 1110
Cleared Feb 26, 1996
AURORA IMAGING SYSTEM
K950837
Advanced Mammography Systems, Inc.
Radiology · 367d
Cleared Jan 18, 1996
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
K954646
Philips Medical Systems (Cleveland), Inc.
Radiology · 100d
Cleared Dec 22, 1995
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
K945945
Philips Medical Systems North America, Inc.
Radiology · 382d
Cleared Nov 24, 1995
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
K942604
GE Medical Systems
Radiology · 541d
Cleared Nov 24, 1995
GYREX PRIVILEGE
K954039
Elscint, Inc.
Radiology · 88d
Cleared Nov 14, 1995
CLINICAL PROTON SPECTROSCOPY OPTION
K951650
Siemens Medical Solutions USA, Inc.
Radiology · 218d
Cleared Nov 14, 1995
ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
K954355
General Electric Co.
Radiology · 57d
Cleared Nov 09, 1995
QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER
K951681
Fonar Corp.
Radiology · 212d
Cleared Oct 23, 1995
IRIS BILATERAL TMJ
K953248
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Oct 17, 1995
QD BILATERAL BREAST COIL
K953262
Hitachi Medical Systems America, Inc.
Radiology · 96d
Cleared Oct 07, 1995
MAGNETOM VISION (PROJECT 016)
K945517
Siemens Medical Solutions USA, Inc.
Radiology · 332d
Cleared Oct 06, 1995
PROFILE 7000 C-SPINE COIL
K943440
Us Asia Instruments, Inc.
Radiology · 445d
Cleared Sep 19, 1995
GYRES 2T PRESTIGE
K945791
Elscint, Inc.
Radiology · 298d
Cleared Sep 18, 1995
OUTLOOK
K945827
Philips Medical Systems (Cleveland), Inc.
Radiology · 293d
Cleared Sep 12, 1995
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K953918
Hitachi Medical Systems America, Inc.
Radiology · 25d
Cleared Aug 30, 1995
HEALTH IMAGE INC. HI STAR
K944724
Health Images, Inc.
Radiology · 339d
Cleared Aug 23, 1995
MAGNETOM VISION (PROJECT 016)
K945779
Siemens Medical Solutions USA, Inc.
Radiology · 271d
Cleared Aug 09, 1995
MEDRAD QWIK-FIX MRI DISPOSABLE KIT
K943189
Medrad, Inc.
Radiology · 400d
Cleared Aug 09, 1995
SIGNA PROFILE
K945730
GE Medical Systems
Radiology · 260d
Cleared Jul 24, 1995
HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE
K952530
Philips Medical Systems (Cleveland), Inc.
Radiology · 53d
Cleared Jul 20, 1995
HEALTH IMAGES, INC. HI-STANDARD
K944228
Health Images, Inc.
Radiology · 323d
Cleared Jun 26, 1995
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15
K952232
Medrad, Inc.
Radiology · 45d
Cleared Jun 26, 1995
MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15
K952235
Medrad, Inc.
Radiology · 45d
Cleared Jun 22, 1995
MODEL #801GE1500 PEDIATRIC ARRAY COIL
K951649
Medic, Inc.
Radiology · 73d