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
481–504 of 1110
Cleared Nov 03, 2004
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
K042948
Wandong Medical
Radiology · 8d
Cleared Oct 04, 2004
G-SCAN
K042236
Esaote, S.P.A.
Radiology · 47d
Cleared Jul 26, 2004
PANORAMA 1.0T
K041602
Philips Medical Systems North America, Inc.
Radiology · 42d
Cleared Jul 23, 2004
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K041695
Usa Instruments, Inc.
Radiology · 31d
Cleared Jul 21, 2004
MAGNETOM ESPREE SYSTEM
K041112
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jul 21, 2004
DYNACAD V1.0
K041286
Mri Devices Corp.
Radiology · 69d
Cleared Jul 16, 2004
MAGNETOM C! MR SYSTEM
K041111
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Jul 07, 2004
CADSTREAM VERSION 3.1
K041020
Confirma, Inc.
Radiology · 78d
Cleared Jun 25, 2004
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K041577
Adac Laboratories
Radiology · 11d
Cleared Jun 17, 2004
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
K041476
Ge Medical Systems, LLC
Radiology · 14d
Cleared May 04, 2004
ARTOSCAN C
K040877
Esaote, S.P.A.
Radiology · 29d
Cleared Apr 20, 2004
ENDOSCOUT
K033485
Robin Medical, Inc.
Radiology · 168d
Cleared Apr 14, 2004
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
K040444
General Electric Co.
Radiology · 85d
Cleared Jan 20, 2004
MRJ
K033507
Paramed S.R.L.
Radiology · 76d
Cleared Dec 19, 2003
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
K033867
General Electric Co.
Radiology · 7d
Cleared Nov 25, 2003
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K033504
General Electric Co.
Radiology · 20d
Cleared Oct 29, 2003
SUPEROPEN 0.23T, MODEL NAM-P023A
K033315
Neusoft Digital Medical Systems Co., Ltd.
Radiology · 14d
Cleared Oct 16, 2003
MAGNETOM AVANTO MR SYSTEM
K032428
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Oct 10, 2003
GE 0.2T SIGNA PROFILE/I MR SYSTEM
K033168
General Electric Co.
Radiology · 10d
Cleared Oct 08, 2003
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
K032795
Ge Medical Systems, LLC
Radiology · 30d
Cleared Sep 29, 2003
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
K032232
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Sep 24, 2003
MODIFICATION TO: AURORA
K032678
Aurora Imaging Technology, Inc.
Radiology · 26d
Cleared Sep 12, 2003
POLESTAR N-20
K032541
Odin Medical Technologies , Ltd.
Radiology · 25d
Cleared Sep 10, 2003
INTERA-SENSATION FAMILY
K031815
Philips Medical Systems
Radiology · 90d