GE Signa HDx 3.0T MRI system

Singapore - English - HSA (Health Sciences Authority)

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Available from:
GE HEALTHCARE PTE. LTD.
Class:
Class B medical device
Manufactured by:
GE Medical Systems LLC
Therapeutic area:
Radiology / Imaging
Therapeutic indications:
Indicated for use as diagnostic imaging devices to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Systems reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis.
Product summary:
Device System Info:[System or Procedure Pack], System; Models: WIDE OPERATOR CONSOLE TABLE - M1000MW, Vibroacoustic Damping Kit - M1060MA, Chiller - M3088TL, GRADIENT HEAT EXCHANGER - M3088TK, TS/HDE MAIN DISCONNT PNL - M3088TM, 3.0T System Electronics - M3340JN, 3.0T System Electronics - M3340JL, 3.0T HDXT SITE COLLECTOR - M3340MW, 3.0T System Phantoms - M3335CC, 3.0T TwinSpeed Magnet & Gradient Package - M3335CK, 3.0T TwinSpeed Magnet & Gradient Package - M3335CL, WIDESCREEN LCD MONITOR - M3335JS, PATIENT TABLE - M3335KF, SIGNA LITE PATIENT TABLE - M3335SL, SIGNA OR COMPATIBLE TABLE - M0001SS, COIL ACCESSARY KIT FOR SS - M0032SS, SIGNA ONCOLOGY TABLE - M0001FT, 3D Myocardial Delayed Enhancement - M3033MD, Navigator 3D - M3033ME, Tricks - M3033MH, FGRE-ET - M3033MP, Cardiac Tagging - M3033MY, Propeller - M3033NH, FiberTrak - M3033NK, 3D Flair - M3033NR, 2D Myocardial Delayed Enhancement - M3090KR, Diffusion Tensor - M3090LR, Sage - M3090MC, Probe-Press - M3333WG, MRS Probe Press Steam - M3333WH, Probe 2DCSI - M3333WJ, 3DCSI - M3333WK, Vibrant Bilateral Breast (3T) - M3335LT, BREASE Breast Single Voxel Spectroscopy - M3335KK, CADstream 5.2 on MR console and AW - M7000JK, CADstream 5.2 Upgrade from 3x, 4.0, 4.1 on MR console and AW - M7000JL, CADstream 5.2 Upgrade from 4.1.3 on MR console only - M7000JJ, CADstream 5.2 Upgrade from 4.1.3 on MR console and AW - M7000GJ, BrainWave Real Time - M3335KR, BrainWave Post Acquisition - M3335KS, BrainWave Fusion - M3335KT, Cartigram T2 Mapping - M3335KY, BRAINWAVE HW HDX/HDI - M3335MJ, Brainwave Hardware upgrade - M3335MK, HDxt ContinuumPak 16.0 - M3340BW, STARMAP Acquisition - M3340AE, SWAN - M3340AG, Cube - M3340AA, IDEAL - M3340AC, 3D ASL - M3340A, 3D ASL - M3340BA, LAVA Flex - M3340AP, eDWI - M3340AR, Cine IR - M3340AT, FGRE Time Course - M3340AW, Inhance Suite - M3340BK, Inhance Delta Flow - M3340BB, 16-ch Head Neck and Spine - M3335HC, 8-ch NV Array - M3334TP, 8-ch Brain Array - M3335LL, 8-ch CTL Array - M3335LM, 6-ch Carotid Array - E8800WC, 8-ch Cardiac Array - M3334TS, 8-ch Breast Array - M3335MF, 8-ch Breast Array - M3335LA, 7-ch Breast Array - E8800BB, 8-ch Torso Array - M3335LN, Disposable Endorectal probe - E8801RK, Endorectal Interface Device - E8801RH, 8-ch T/R Knee Array - M3335LB, 8-ch Foot/Ankle Array - M3340CB, Quad Extremity (Knee/Foot) - M3335LP, 8-ch Shoulder Coil - M3340CC, 3-ch Shoulder Array - M3335LR, 8-ch Wrist Array - M3340CA, Quad Small Extremity Wrist - E8800R, 6-ch Flex Coil; Hypertonic connector - M0005SS, GP Flex - M1385AF, Optima Edition 23 ScanTools Upgrade Pak 3.0T  - - M3341AJ, Cube 2.0 with T2, T2 FLAIR, PD, and T1 - M7000HZ, PROPELLER 3.0 - M7000JA, PROPELLER Upgrade to 3.0 - M3341AE, PROPELLER 1.0 to HD23 Transfer - M3341AN, READY Brain - M7000JH, BrainStat with AIF - M7000FC, Flow Analysis 4.0 on Console - M7000EZ, 3D Heart (New for 3T.  Includes Cine IR, 3D MDE, & Navigator) - M3340AY, Service IP Protection Disable - M7000JT, Express Exam Host Computer Upgrade - M3341AH, VRE Upgrade 8/16-Channel - M3341JD, VRE Upgrade 32-Channel - M3341JA, 3.0T EXCITE to HD23 RF Amp Board  Hardware (no MNS) - M3341AP, 3.0T EXCITE  to HD23 RF Amp Board (external MNS Amp) - M3341AR, 3.0T EXCITE to HD23 RF Amp Board (internal MNS Amp) - M3341AS
Authorization number:
DE0012413
Authorization date:
2013-02-19

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