Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. the system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. the system is a nuclear medicine (nm) system, which is intended to yield general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. the system may include signal analysis and display equipment, patient and equipment supports, components and accessories. the system may be used for patients of all ages.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - viewpoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound. viewpoint 6 provides the user the ability to include images, drawings, and charts into medical reports. viewpoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. the medical images, which viewpoint 6 displays to the user, can be used for diagnostic purposes. viewpoint 6 is intended for professional use only. viewpoint 6 is not intended to be used as an automated diagnosis system. viewpoint 6 is not intended to operate medical devices in surgery related procedures.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - the apexpro telemetry system is intended for use under the direct supervision of a licensed healthcare practitioner. the system provides physiological data for ambulatory adult and pediatric patients within a hospital or clinical environment. the system processes physiological data to detect various ecg events and select physiological parameter violations. the apexpro telemetry system is intended to be used in conjunction with a central station for the display of monitoring data, alarm annunciation, printing and system setting adjustments. the physiological data monitored include values and waveforms for ecg and spo2 values. apexpro provides beat to beat patient information, parameter values and ecg waveforms over the carescape network for display on a viewing device.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - is intended for use under the direct supervision of a licensed healthcare practitioner. the system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. the system processes this physiological data to detect various ecg arrhythmia events and select physiological parameter limit violations. the apexpro telemetry system is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. these systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered. the physiological parameters monitored include ecg, non-invasive blood pressure, non-invasive temperature and spo2. the apexpro telemetry system is intended to provide ecg data via ethernet to the computer platform for processing.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - 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 direct supervision of a licensed health care practitioner.not intended for use during mri. can be a stand-alone monitor or interfaced to other devices via a network. monitors and displays oscillometric noninvasive blood pressure (systolic, diastolic and mean arterial pressure),invasive blood pressure, end-tidal co2, heart/pulse rate,respiration rate,ecg(incl. arrhythmia and st segment analysis),temperature with a reusable or disposable electronic thermometer for continual monitoring esophageal/nasopharyngeal/tympanic/rectal/bladder/axillary/skin/airway/room/myocardial/core/surface temperature, functional oxygen saturation (spo2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion and entropy.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the ge brivo ct385 computed tomography x-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including axial, cine, helical. these images may be obtained either with or without contrast. this device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. this device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. further the images can be post processed to produce additional imaging planes or analysis results. the ge brivo ct385 ct scanner system is indicated for head, whole body, and vascular x-ray computed tomography applications. the device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the brivo mr355 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. it is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. depending on the region of interest being imaged, contrast agents may be used. the images produced by the brivo mr355 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. these images and/or spectra 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 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. the system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. the system is a nuclear medicine (nm) system, which is intended to yield general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. scanning modes include planar mode (static, multi-gated, dynamic and whole body scanning) and tomographic mode (spect, gated spect, whole body spect). the acquisition types include single and multi-isotope/multi peak frame/list

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the cardiolab system 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, intracardiac signals, stimulus data, ablation data, pulse oximetry (spo2), respiration rate, co2 (etco2), temperature, and invasive and noninvasive blood pressure.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - cardiosoft is designed to acquire, process, record, archive, analyze and output ecg data (12 and 15 leads) during a period of physiologic stress or during a resting ecg test and acquire data from ancillary devices, such as spirometry and ambulatory blood pressure devices. furthermore, it provides median morphology recordings and records ecg in real-time with and without arrhythmia detection (does not provide alarms). cardiosoft cardiac testing system is intended to be used by trained operators under direct supervision of a licensed healthcare practitioner on adult and pediatric patients.