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
1997-10-15
LNH
1997-09-29
KINEMATIC POSITIONERS
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LNH
1997-08-25
GYREX PRIMA 1TG 1.0T MRI SYSTEM
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LNH
1997-08-20
ASSET APOLLO
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LNH
1997-08-05
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
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LNH
1997-07-24
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
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LNH
1997-07-21
FLEXART V3.5 SOFTWARE
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LNH
1997-07-15
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
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LNH
1997-07-03
MEDRAD FLEX INTERFACE DEVICE
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LNH
1997-07-03
VERSION 4 OPERATING SYSTEM SOFTWARE
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LNH
1997-06-20
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
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LNH
1997-06-16
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
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LNH
1997-06-05
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
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LNH
1997-05-29
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
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LNH
1997-03-28
ARTOSCAN M
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LNH
1997-03-12
TARGOGRID
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LNH
1997-02-24
HI-STAR MRI IMAGING SYSTEM
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LNH
1997-02-24
KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER
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LNH
1997-02-11
MATRIX 3000 FLEXIBLE SPINE COIL
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LNH
1997-02-10
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
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LNH
1997-02-04
MRT-35A V9.0
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LNH
1997-01-24
PROFILE 70000 QUADRATURE VOLUME NECK COIL
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LNH
1997-01-17
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
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LNH
1997-01-10
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
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LNH
1997-01-10
PIXELL MRI SYSTEM
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LNH
1996-12-23
FLEXART V3.1 SOFTWARE
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LNH
1996-12-18
IMIG-MRI
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LNH
1996-11-27
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
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LNH
1996-11-27
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
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LNH
1996-11-12
ORTHO 8000
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LNH
1996-11-07
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
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LNH
1996-10-29
HELAX TMS BRACHYTHERAPY, VERSION 3.0
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LNH
1996-10-25
OPART MRT-600
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LNH
1996-10-18
ADVANTAGE WINDOWS TISSUE VOLUME OPTION
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LNH
1996-10-18
FLEXART TMJ COIL
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LNH
1996-09-25
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
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LNH
1996-09-20
ESTEEM 1.5T MRI SYSTEM
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LNH
1996-09-05
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE
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LNH
1996-09-04
GYREX V-EP
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LNH
1996-08-27
QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
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LNH
1996-08-14
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
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LNH
1996-08-02
SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM
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LNH
1996-07-25
AIRIS
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LNH
1996-07-05
FLEXIBLE PHASED ARRAY SPINE COIL
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LNH
1996-07-03
MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
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LNH
1996-06-28
MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1
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LNH
1996-06-21
ECG MONITOR MODEL DS-3130/3140
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LNH
1996-06-19
KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM
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LNH
1996-06-14
VISART
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LNH
1996-06-10
MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
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LNH
1996-05-29
MOVABLE ADD-ON COUCH FOR OUTLOOK
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LNH
1996-05-29
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
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LNH
1996-04-19
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
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LNH
1996-04-12
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
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LNH
1996-04-12
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
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LNH
1996-03-29
AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
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LNH
1996-03-05
VERSION 3.7 OPERATING SYSTEM SOFTWARE
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LNH
1996-02-26
AURORA IMAGING SYSTEM
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LNH
1996-01-18
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
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LNH
1995-12-22
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
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LNH
1995-11-24
GYREX PRIVILEGE
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LNH
1995-11-24
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
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LNH
1995-11-14
ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
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LNH
1995-11-14
CLINICAL PROTON SPECTROSCOPY OPTION
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LNH
1995-11-09
QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER
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LNH
1995-10-23
IRIS BILATERAL TMJ
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LNH
1995-10-17
QD BILATERAL BREAST COIL
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LNH
1995-10-07
MAGNETOM VISION (PROJECT 016)
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LNH
1995-10-06
PROFILE 7000 C-SPINE COIL
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LNH
1995-09-19
GYRES 2T PRESTIGE
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LNH
1995-09-18
OUTLOOK
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LNH
1995-09-12
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
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LNH
1995-08-30
HEALTH IMAGE INC. HI STAR
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LNH
1995-08-23
MAGNETOM VISION (PROJECT 016)
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LNH
1995-08-09
SIGNA PROFILE
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LNH
1995-08-09
MEDRAD QWIK-FIX MRI DISPOSABLE KIT
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LNH
1995-07-24
HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE
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LNH
1995-07-20
HEALTH IMAGES, INC. HI-STANDARD
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LNH
1995-06-26
MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15
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LNH
1995-06-26
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15
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LNH
1995-06-22
MODEL #801GE1500 PEDIATRIC ARRAY COIL
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LNH
1995-06-19
ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING
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LNH
1995-06-19
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS
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LNH
1995-06-13
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
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LNH
1995-06-05
THIN-FILM CARDIAC GATING CABLE
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LNH
1995-05-24
AIRIS
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LNH
1995-05-12
MRH-1500
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LNH
1995-05-11
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
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LNH
1995-04-20
MRT-50 QD BODY COIL
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LNH
1995-04-12
ECHO PLANAR IMAGING I
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LNH
1995-04-10
ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)
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LNH
1995-04-06
MRT-35A UPGRADE 8.0CD
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LNH
1995-04-06
FLEXART(TM) QD C-SPINE COIL
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LNH
1995-03-23
PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL
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LNH
1995-03-21
STRATIS
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LNH
1995-02-09
ANGIO II
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LNH
1995-02-08
ACCESS(TM) COMPASS BED
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LNH
1995-02-02
SMT-50CX/H
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LNH
1995-01-26
MRT-150A, MRT-150A SOFTWARE VERSION 11.9
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LNH
1995-01-26
ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION
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