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..

1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
433–456 of 1104
Cleared Sep 07, 2005
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
K052078
Philips Medical Systems Nederland B.V.
Radiology · 37d
Cleared Aug 02, 2005
ACHIEVA 1.5T & INERA 1.5T FAMILY
K052013
Philips Medical Systems Nederland B.V.
Radiology · 7d
Cleared Apr 07, 2005
ALTAIRE
K050602
Hitachi Medical Systems America, Inc.
Radiology · 29d
Cleared Mar 18, 2005
STARSHIELD V3 RF TRNT
K050237
Odin Medical Technologies , Ltd.
Radiology · 44d
Cleared Feb 28, 2005
MAGNETOM TRIO A TIM SYSTEM
K050200
Siemens Medical Solutions USA, Inc.
Radiology · 31d
Cleared Feb 18, 2005
MAGNETOM SYMPHONY A TIM SYSTEM
K050199
Siemens Medical Solution
Radiology · 21d
Cleared Feb 15, 2005
ACHIEVA FAMILY
K043147
Philips Medical Systems North America Co.
Radiology · 92d
Cleared Feb 15, 2005
NEURO II-S
K050132
Innovative Magnetic Resonance Imaging Systems, Inc.
Radiology · 25d
Cleared Jan 28, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
K043290
Neurognostics, Inc.
Radiology · 60d
Cleared Jan 21, 2005
R2-MRI ANALYSIS SYSTEM
K043271
Inner Vision Biometrics Pty, Ltd.
Radiology · 56d
Cleared Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262
Ge Healthcare
Radiology · 49d
Cleared Dec 09, 2004
MAGNETOM C! MR SYSTEM
K043030
Siemens Medical Solutions
Radiology · 36d
Cleared Nov 24, 2004
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
K043112
General Electric Co.
Radiology · 14d
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 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