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
601–624 of 1101
Cleared Nov 22, 1993
0.5T ASSET SYSTEM
K933835
Philips Medical Systems (Cleveland), Inc.
Radiology · 109d
Cleared Nov 12, 1993
ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000
K933645
Hitachi Medical Systems America, Inc.
Radiology · 108d
Cleared Nov 08, 1993
PHILIPS GYROSCAN ACS-II RELEASE 3
K930709
Philips Medical Systems, Inc.
Radiology · 270d
Cleared Nov 01, 1993
ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY
K930960
Toshiba America Mri, Inc.
Radiology · 250d
Cleared Oct 28, 1993
PHILIPS MRI BREAST COIL
K926275
Philips Medical Systems, Inc.
Radiology · 318d
Cleared Oct 25, 1993
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K932344
Siemens Medical Solutions USA, Inc.
Radiology · 164d
Cleared Oct 08, 1993
MRT-50A, MRT-150A
K926001
Toshiba America Mri, Inc.
Radiology · 315d
Cleared Oct 07, 1993
MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE
K925286
Toshiba America Mri, Inc.
Radiology · 352d
Cleared Oct 07, 1993
GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0
K925985
Elscint, Inc.
Radiology · 316d
Cleared Oct 07, 1993
MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15
K930779
Medrad, Inc.
Radiology · 233d
Cleared Oct 07, 1993
ARTOSCAN
K931022
Biosound, Inc.
Radiology · 220d
Cleared Oct 07, 1993
EDGE SYSTEM
K932693
Philips Medical Systems (Cleveland), Inc.
Radiology · 126d
Cleared Sep 29, 1993
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15
K930544
Medrad, Inc.
Radiology · 239d
Cleared Sep 16, 1993
MODEL 640GE-64: QUADRATURE PELVIC COIL
K930674
Medical Advances, Inc.
Radiology · 219d
Cleared Sep 07, 1993
MODIFIED BODY HELMHOLTZ COIL
K930811
Siemens Medical Solutions USA, Inc.
Radiology · 202d
Cleared Sep 07, 1993
MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL
K932374
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Sep 07, 1993
MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI
K932375
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Aug 30, 1993
MAGNETOM P8
K932338
Siemens Medical Solutions USA, Inc.
Radiology · 108d
Cleared Aug 26, 1993
AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS
K932292
Medrad, Inc.
Radiology · 108d
Cleared Jul 26, 1993
MODEL #QSC-200-21 20 CM. QUADRATURE SHOULDER COIL
K930045
Mri Devices Corp.
Radiology · 202d
Cleared Jul 26, 1993
MODEL 600GE-64: BILATERAL BREAST COIL
K930122
Medical Advances, Inc.
Radiology · 195d
Cleared Jul 20, 1993
MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15
K926571
Medrad, Inc.
Radiology · 201d
Cleared Jun 18, 1993
MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL
K931008
Mri Devices Corp.
Radiology · 112d
Cleared Jun 08, 1993
MRH-1500
K922846
Hitachi Medical Systems America, Inc.
Radiology · 358d