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
793–816 of 1110
Cleared Feb 24, 1994
AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN
K932403
Medrad, Inc.
Radiology · 297d
Cleared Feb 18, 1994
SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM
K932244
Shimadzu Medical Systems
Radiology · 284d
Cleared Feb 18, 1994
MRT-50GP
K933018
Toshiba America Mri, Inc.
Radiology · 241d
Cleared Feb 09, 1994
SPORTS MEDICINE QUADRATURE SHOULDER COIL
K932552
Magnetic Research, Inc.
Radiology · 259d
Cleared Feb 09, 1994
INCREASED SAR PACKAGE FOR MRT-150A
K935084
Toshiba America Mri, Inc.
Radiology · 107d
Cleared Jan 25, 1994
PHILIPS GYROSCAN T5 II RELEASE 3
K930708
Philips Medical Systems, Inc.
Radiology · 348d
Cleared Jan 25, 1994
HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION
K934485
Hitachi Medical Systems America, Inc.
Radiology · 133d
Cleared Jan 18, 1994
SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM
K931298
General Electric Co.
Radiology · 309d
Cleared Jan 07, 1994
MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016
K932271
Siemens Medical Solutions USA, Inc.
Radiology · 254d
Cleared Jan 05, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
K934719
Hitachi Medical Systems America, Inc.
Radiology · 96d
Cleared Dec 27, 1993
FAST SPIN ECHO
K934212
Hitachi Medical Systems America, Inc.
Radiology · 119d
Cleared Dec 23, 1993
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K934499
GE Medical Systems
Radiology · 100d
Cleared Dec 14, 1993
IMAGEACCESS SYSTEM
K931454
Image Premastering Services, Inc.
Radiology · 266d
Cleared Dec 14, 1993
MERIT
K931656
Picker International
Radiology · 253d
Cleared Dec 14, 1993
PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL
K932091
Magnetic Research, Inc.
Radiology · 228d
Cleared Dec 14, 1993
MERIT
K933356
Philips Medical Systems (Cleveland), Inc.
Radiology · 158d
Cleared Dec 13, 1993
PHILIPS GYROSCAN TN5 & TN5 LITE
K932644
Philips Medical Systems, Inc.
Radiology · 194d
Cleared Dec 13, 1993
PHILIPS GYROSCAN TN 15
K932645
Philips Medical Systems, Inc.
Radiology · 194d
Cleared Dec 02, 1993
OE 1.5 SI
K925858
Otsuka Electronics
Radiology · 380d
Cleared Nov 24, 1993
QUADRATURE LOWER EXTREMITY COIL
K934396
Medical Advances, Inc.
Radiology · 76d
Cleared Nov 22, 1993
1.5T EDGE AND 1.0T VISTA SYSTEMS
K931544
Philips Medical Systems (Cleveland), Inc.
Radiology · 238d
Cleared Nov 22, 1993
MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL
K933659
Medic, Inc.
Radiology · 118d
Cleared Nov 22, 1993
0.5T ASSET SYSTEM
K933835
Philips Medical Systems (Cleveland), Inc.
Radiology · 109d
Cleared Nov 19, 1993
MODEL 300GE1500 SHOULDER COIL
K933658
Medic, Inc.
Radiology · 115d