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
361–384 of 1101
Cleared Feb 28, 2005
MAGNETOM TRIO A TIM SYSTEM
K050200
Siemens Medical Solutions USA, Inc.
Radiology · 31d
Cleared Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262
Ge Healthcare
Radiology · 49d
Cleared Nov 24, 2004
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
K043112
General Electric Co.
Radiology · 14d
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 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 14, 2004
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
K040444
General Electric Co.
Radiology · 85d
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 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 10, 2003
INTERA-SENSATION FAMILY
K031815
Philips Medical Systems
Radiology · 90d
Cleared Aug 21, 2003
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
K032490
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Aug 13, 2003
MODIFICATION TO E-SCAN XQ
K032121
Esaote, S.P.A.
Radiology · 35d
Cleared Jul 02, 2003
GE DELTA SOFTWARE OPTION FOR MRI
K031927
GE Medical Systems
Radiology · 9d
Cleared Jun 24, 2003
ECLIPSE
K030981
Varian Medical Systems, Inc.
Radiology · 88d