Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the optima xr240amx is intended to take exposures utilizing film, computed radiography, or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography. the optima xr240amx is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional rad room. the system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position. it is not intended for mammographic applications.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - 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.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the amx navigate is intended to take exposures utilizing film, computed radiography (cr), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (dr). the amx navigate is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. the system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position. this device is not intended for mammographic applications.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - 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.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - 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.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended for head and whole body attenuation corrected pet imaging and localization of emission activity in patient anatomy by means of integrated pet and ct images, and to be used by trained healthcare professionals for imaging the distribution of radiopharmaceuticals in the body for assessment of metabolic (molecular) and physiologic functions in patients of all ages. it 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. it can assist in radiotherapy planning and can be used as a stand-alone head and whole body multi-slice ct diagnostic imaging system. the lung cancer screening option is indicated for using low-dose ct for lung cancer screening, which must be performed within the established inclusion criteria of programs/protocols that have been approved and published by a governmental body or professional medical society.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the bone densitometer is designed to estimate the bone mineral density of patients when medically indicated by their physicians. provides an estimate of bone mineral density at various anatomical sites (spine, femur, forearm). these values can then be compared to an adult reference population at the sole discretion of the physician. provides an assessment of relative fracture risk based on the patient's t-score value using the categories of fracture risk defined by the world health organization (who). provides an assessment of 10-year fracture risk using who frax model. provides a standardized bone density report using data from the densitometer and physician-generated assessments based on the patient's demographics, which can assist the physician in communicating scan results to the patient and the patient's referring physician.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. intended for use under the direct supervision of a licensed health care practitioner. not intended for use during mri. monitor can be a stand-alone monitor or interfaced to other devices via network. the monitors and displays: ecg, invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure functional oxygen saturation (spo2) and pulse rate via continuous monitoring(including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring esophageal/nasopharyngeal/tympanic/rectal/bladder/axillary/skin/airway/room/myocardial/ core/surface temperature, impedance respiration, respiration rate, airway gases, c.o. and entrophy.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the combolab system is the combination of both the mac-lab and cardiolab systems and is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. clinical data includes: ecg waveforms, heart rate, pulse oximetry (spo2), respiration rate, co2 (etco2), temperature, hemodynamic measures (for example, valve gradients and areas, cardiac output, shunts, fractional flow reserve (ffr), invasive and noninvasive blood pressure), intracardiac signals, stimulus data and ablation data.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the angiographic x-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non- vascular, diagnostic and interventional procedures. additionally, with the or table, the angiographic x-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.