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
2007-05-10
LNH
2007-01-04
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
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LNH
2006-11-21
EXCELART VANTAGE ATLAS, MODEL MRT-1503
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LNH
2006-11-09
S-SCAN MRI SYSTEM
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LNH
2006-11-03
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
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LNH
2006-10-27
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
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LNH
2006-08-11
NEURO II-SE, MODELS OR-MB-DR AND OR-DR
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LNH
2006-07-28
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
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LNH
2006-07-28
DIAGNOSOFT HARP
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LNH
2006-07-25
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
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LNH
2006-06-13
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
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LNH
2006-05-24
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
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LNH
2006-05-04
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
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LNH
2006-01-24
ALTAIRE INTERVENTIONAL MR PACKAGE
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LNH
2006-01-18
EXCELART VANTAGE ZGV
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LNH
2006-01-13
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
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LNH
2005-12-08
CADIMAS VERSION 1.0
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LNH
2005-11-17
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
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LNH
2005-11-09
GE 1.5T SIGNA HDE MR SYSTEM
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LNH
2005-11-08
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
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LNH
2005-11-08
MODIFICATION TO: AURORA
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LNH
2005-10-17
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
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LNH
2005-10-04
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
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LNH
2005-09-27
PORTAL GRAVITY SYSTEM
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LNH
2005-09-27
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
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LNH
2005-09-22
SIMTEC IM-MAXX 2 OPTION
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LNH
2005-09-21
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
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LNH
2005-09-08
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
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LNH
2005-09-07
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
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LNH
2005-08-02
ACHIEVA 1.5T & INERA 1.5T FAMILY
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LNH
2005-04-07
ALTAIRE
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LNH
2005-03-18
STARSHIELD V3 RF TRNT
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LNH
2005-02-28
MAGNETOM TRIO A TIM SYSTEM
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LNH
2005-02-18
MAGNETOM SYMPHONY A TIM SYSTEM
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LNH
2005-02-15
NEURO II-S
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LNH
2005-02-15
ACHIEVA FAMILY
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LNH
2005-01-28
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
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LNH
2005-01-21
R2-MRI ANALYSIS SYSTEM
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LNH
2005-01-12
GE SIGNA EXCITE MR SURGICAL OPTION
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LNH
2004-12-09
MAGNETOM C! MR SYSTEM
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LNH
2004-11-24
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
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LNH
2004-11-03
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
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LNH
2004-10-04
G-SCAN
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LNH
2004-07-26
PANORAMA 1.0T
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LNH
2004-07-23
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
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LNH
2004-07-21
DYNACAD V1.0
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LNH
2004-07-21
MAGNETOM ESPREE SYSTEM
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LNH
2004-07-16
MAGNETOM C! MR SYSTEM
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LNH
2004-07-07
CADSTREAM VERSION 3.1
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LNH
2004-06-25
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
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LNH
2004-06-17
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
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LNH
2004-05-04
ARTOSCAN C
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LNH
2004-04-20
ENDOSCOUT
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LNH
2004-04-14
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
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LNH
2004-01-20
MRJ
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LNH
2003-12-19
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
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LNH
2003-11-25
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
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LNH
2003-10-29
SUPEROPEN 0.23T, MODEL NAM-P023A
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LNH
2003-10-16
MAGNETOM AVANTO MR SYSTEM
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LNH
2003-10-10
GE 0.2T SIGNA PROFILE/I MR SYSTEM
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LNH
2003-10-08
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
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LNH
2003-09-29
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
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LNH
2003-09-24
MODIFICATION TO: AURORA
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LNH
2003-09-12
POLESTAR N-20
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LNH
2003-09-10
INTERA-SENSATION FAMILY
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LNH
2003-08-21
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
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LNH
2003-08-13
MODIFICATION TO E-SCAN XQ
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LNH
2003-07-30
AURORA
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LNH
2003-07-30
MR FIBER OPTIC ECG GATING SYSTEM
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LNH
2003-07-02
GE DELTA SOFTWARE OPTION FOR MRI
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LNH
2003-06-24
ECLIPSE
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LNH
2003-06-23
3TP SOFTWARE OPTION
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LNH
2003-05-13
ADVANTAGE WORKSTATION PASTING 1.1
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LNH
2003-05-02
GE PROPELLER IMAGING OPTION FOR MRI
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LNH
2003-04-01
SUPEROPEN 0.35T, MODEL NSM-P035
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LNH
2003-03-28
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
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LNH
2003-03-06
INTERA FAMILY
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LNH
2003-02-04
INFINION SOFTWARE FEATURES
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LNH
2003-02-04
PANORAMA ENHANCEMENTS
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LNH
2003-01-29
AURORA MR-GUIDED INTERVENTIONAL SYSTEM
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LNH
2002-11-05
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
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LNH
2002-10-11
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
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LNH
2002-10-11
HITACHI ALTAIRE
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LNH
2002-10-09
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
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LNH
2002-08-28
RF TENT
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LNH
2002-08-22
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
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LNH
2002-06-13
SYNGO MR 2002B
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LNH
2002-04-25
ISAAC 1.5 T MR SYSTEM
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LNH
2002-04-24
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
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LNH
2002-03-13
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
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LNH
2002-02-12
E-SCAN XQ
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LNH
2002-02-05
CANVAS N-VAS-D 2.0
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LNH
2002-01-24
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
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LNH
2002-01-22
INFINION 0.6T MR IMAGING SYSTEM
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LNH
2001-12-28
MAGNETOM TRIO SYSTEM
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LNH
2001-12-17
POLESTAR N-10
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LNH
2001-12-11
INTERA I/T
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LNH
2001-11-20
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
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LNH
2001-10-31
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
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LNH
2001-10-18
MR-GUIDE 2000
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