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..
1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
Cleared
Sep 07, 2005
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
Philips Medical Systems Nederland B.V.
Radiology
37d
Cleared
Aug 02, 2005
ACHIEVA 1.5T & INERA 1.5T FAMILY
Philips Medical Systems Nederland B.V.
Radiology
7d
Cleared
Apr 07, 2005
ALTAIRE
Hitachi Medical Systems America, Inc.
Radiology
29d
Cleared
Mar 18, 2005
STARSHIELD V3 RF TRNT
Odin Medical Technologies , Ltd.
Radiology
44d
Cleared
Feb 28, 2005
MAGNETOM TRIO A TIM SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
31d
Cleared
Feb 18, 2005
MAGNETOM SYMPHONY A TIM SYSTEM
Siemens Medical Solution
Radiology
21d
Cleared
Feb 15, 2005
ACHIEVA FAMILY
Philips Medical Systems North America Co.
Radiology
92d
Cleared
Feb 15, 2005
NEURO II-S
Innovative Magnetic Resonance Imaging Systems, Inc.
Radiology
25d
Cleared
Jan 28, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
Neurognostics, Inc.
Radiology
60d
Cleared
Jan 21, 2005
R2-MRI ANALYSIS SYSTEM
Inner Vision Biometrics Pty, Ltd.
Radiology
56d
Cleared
Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
Ge Healthcare
Radiology
49d
Cleared
Dec 09, 2004
MAGNETOM C! MR SYSTEM
Siemens Medical Solutions
Radiology
36d
Cleared
Nov 24, 2004
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
General Electric Co.
Radiology
14d
Cleared
Nov 03, 2004
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
Wandong Medical
Radiology
8d
Cleared
Oct 04, 2004
G-SCAN
Esaote, S.P.A.
Radiology
47d
Cleared
Jul 26, 2004
PANORAMA 1.0T
Philips Medical Systems North America, Inc.
Radiology
42d
Cleared
Jul 23, 2004
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
Usa Instruments, Inc.
Radiology
31d
Cleared
Jul 21, 2004
MAGNETOM ESPREE SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
84d
Cleared
Jul 21, 2004
DYNACAD V1.0
Mri Devices Corp.
Radiology
69d
Cleared
Jul 16, 2004
MAGNETOM C! MR SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
79d
Cleared
Jun 25, 2004
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
Adac Laboratories
Radiology
11d
Cleared
Jun 17, 2004
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
Ge Medical Systems, LLC
Radiology
14d
Cleared
May 04, 2004
ARTOSCAN C
Esaote, S.P.A.
Radiology
29d
Cleared
Apr 14, 2004
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
General Electric Co.
Radiology
85d