System, Nuclear Magnetic Resonance Imaging
FDA product code LNH · 1071 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.1000
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1988-09-02 – 2026-09-16
LNH
2001-09-27
LNH
2001-09-24
GE SIGNA ASSET IMAGING OPTION
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LNH
2001-09-19
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
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LNH
2001-08-06
MUSCLE IMAGING SYSTEM (MIS)
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LNH
2001-08-03
1.5T INFINITY TWINSPEED MR SYSTEM
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LNH
2001-07-19
INFINION ENHANCEMENT PACKAGE
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LNH
2001-06-06
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
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LNH
2001-06-06
QED DIODE DETECTORS, MODELS 1112-1116
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LNH
2001-05-30
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
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LNH
2001-05-24
ULTRAGUIDE MR-GUIDE 3000
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LNH
2001-05-08
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
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LNH
2001-04-11
FIESTA IMAGING OPTION
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LNH
2001-04-09
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
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LNH
2001-03-15
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
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LNH
2001-03-13
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
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LNH
2001-02-21
AURORA
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LNH
2001-02-13
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
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LNH
2001-02-02
MODIFICATION TO ARTOSCAN M
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LNH
2001-01-23
MAGNETOM RHAPSODY SYSTEM
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LNH
2001-01-23
DIFFUSION TENSOR IMAGING OPTION
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LNH
2001-01-18
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS
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LNH
2000-12-27
GYROSCAN INTERA 3.0T
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LNH
2000-12-21
INTERACTIVE REAL TIME SCANNING PACKAGE
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LNH
2000-12-21
MAGNETIC CONCERTO
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LNH
2000-12-19
NEURO II
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LNH
2000-10-31
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
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LNH
2000-10-26
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
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LNH
2000-10-17
HITACHI ALTAIRE
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LNH
2000-10-11
MAGNETOM ALLEGRA SYSTEM
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LNH
2000-10-03
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
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LNH
2000-09-20
POLESTAR N-10
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LNH
2000-09-06
EXPLORER GRADIENT
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LNH
2000-09-06
GYROSCAN INTERA (R7.5)
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LNH
2000-08-30
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
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LNH
2000-08-18
POWERDRIVE 350 OPTION
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LNH
2000-08-18
ORTHONE
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LNH
2000-08-08
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
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LNH
2000-07-06
MODIFICATION TO E-SCAN
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LNH
2000-07-06
HITACHI AIRIS II
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LNH
2000-05-26
SPIRAL IMAGING OPTION
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LNH
2000-04-27
STEROTACTIC LOCALIZATION DEVICE (SLD)
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LNH
2000-03-27
VENTRICULAR ANALYSIS TOOLKIT OPTION
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LNH
2000-03-22
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
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LNH
2000-03-16
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
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LNH
2000-03-02
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
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LNH
2000-02-06
EXCELART WITH PIANISSIMO
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LNH
2000-02-04
MR ENHANCER
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LNH
2000-01-20
MRI EQUIPMENT COVER
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LNH
2000-01-18
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
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LNH
2000-01-14
MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
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LNH
1999-12-23
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
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LNH
1999-12-07
PHILIPS EASYVISION WORKSTATION
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LNH
1999-11-09
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
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LNH
1999-11-01
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
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LNH
1999-10-18
PHILIPS GYROSCAN INTERA (*)
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LNH
1999-10-08
VIRGO MRI SYSTEM
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LNH
1999-10-05
PREFERENCE TREATMENT SYSTEM
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LNH
1999-09-16
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
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LNH
1999-09-09
PHILIPS EASYVISION WORKSTATION:
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LNH
1999-09-08
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
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LNH
1999-09-07
QUANTITATIVE FLOW
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LNH
1999-08-23
MRGP OPTICAL TRACKING UNIT
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LNH
1999-08-17
IPASS BOLUS TRACKING
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LNH
1999-08-13
DYNAWELL OR DYNAWELL
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LNH
1999-08-03
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
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LNH
1999-06-18
NORMA 10
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LNH
1999-05-27
E-SCAN
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LNH
1999-05-14
EXCELART
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LNH
1999-05-11
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
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LNH
1999-04-15
OPART
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LNH
1999-02-25
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
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LNH
1999-02-12
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
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LNH
1999-02-08
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
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LNH
1999-02-02
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS
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LNH
1999-01-25
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
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LNH
1999-01-07
FIELD EFFECTS MRI SYSTEM
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LNH
1998-11-03
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
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LNH
1998-11-02
MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC
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LNH
1998-10-29
RESTGRID PACKAGE/GYROSCAN NT
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LNH
1998-10-22
JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031
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LNH
1998-10-09
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS
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LNH
1998-09-02
TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE
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LNH
1998-08-27
IMAGE POST-PROCESSING TECHNIQUES
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LNH
1998-08-03
ORTHOVU-1000
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LNH
1998-07-14
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE
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LNH
1998-06-30
HAMMERSMITH ENDOCAVITARY COILS
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LNH
1998-06-30
HIGH IMPEDANCE CARDIAC GATING CABLE
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LNH
1998-06-01
ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
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LNH
1998-05-11
PHILIPS GYROSCAN NT RELEASE 6 SERIES
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LNH
1998-05-06
DIFFUSION PACKAGE / GYROSCAN NT
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LNH
1998-05-04
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V
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LNH
1998-04-02
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
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LNH
1998-03-30
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
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LNH
1998-03-10
OUTLOOK SYSTEM ENHANCEMENT PACKAGE
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LNH
1998-03-04
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102
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LNH
1998-02-26
STRATIS II
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LNH
1998-02-09
AIRIS II
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LNH
1998-02-06
DUFFUSION-WEIGHTED MR IMAGING PACKAGE
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LNH
1998-02-05
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
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LNH
1998-01-02
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
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