GE Discovery STE 8 System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

GE HEALTHCARE PTE. LTD.

Class:

Class C medical device

Manufactured by:

GE Medical Systems LLC

Therapeutic area:

Radiology / Imaging

Therapeutic indications:

The GE Discovery STE system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery STE system is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery STE system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system.

Product summary:

Device System Info:[System or Procedure Pack], The system is comprised of a gantry, patient table, power distribution unit, and reconstruction hardware.; Models: Discovery STE 8 Base - S9118LM, Discovery STE 8 - S9118LE, Discovery STE 8 Base Mobile - S9118ML, Discovery STE 8 Mobile - S9118ME, VUE Point HD - P5051LW, RadRX & Xtream FX Advanced CT - P5051LR, 4Dx - P5051LY, ACQC - P5051LC, WideView - P5051LZ, Oncology Workstation w/ FULL Sim MD Oncology Workstation w/ BASIC Sim MD - S7803CY, Additional LCD Flat panel monitor for AW - M80281FR, Discovery SmartStep w/ monitor - P5050SM, Discovery SmartStep w/out monitor - P5050SN, PET VCAR - P50821CB, PET VCAR Floating License - P50821CD, Discovery Advantage 4D - P5850JF, Varian RPM Respiratory Patient monitor & Install - E8819KA, Varian RPM Mounting Bracket for DST/DSTE - E8819HA, RTP Flat Table Top - Civco - E8505MJ, MEDTECH PET Patient Positioning Kit - S9200PL, Cardiac PET Only – - S9113RB, Cardiac PET & CT Calcium Scoring – - S9113RC, Cardiac PET & CT Coronary Angiography – - S9113RD, CardIQ Xpress 2.0 Elite AW VolumeShare2 - B79821SE, CardIQ Function Xpress - B79821TD, AW VolumeShare2 Productivity Pack – 12GB RAM - M81521PE, Disc STE/VCT IVY 3150B ECG Cardiac Trigger - E8007TA, ECG Simulator - E8007MH, ECG Simulator Adapter - E8007MJ, ECTool Box 2.6 for AW - P58501JH, CardIQ Fusion (PET Only) - P51801BP, CardIQ Fusion (PET & SPECT) - P51821BB, CardIQ Physio - P50801BF, Dynamic VUE - P50801TE

Authorization date:

2011-02-18