Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended to be used for head, whole body computed tomography applications. the 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, including axial, cine, helical (volumetric), cardiac, and gated acquisitions. 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 system is indicated for head, whole body, cardiac and vascular x-ray computed tomography applications in patients of all ages.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended to be used for head, whole body computed tomography applications. the 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, including axial, cine, helical (volumetric), cardiac, and gated acquisitions. 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 system is indicated for head, whole body, cardiac and vascular x-ray computed tomography applications in patients of all ages.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - ca1000 is intended for viewing and diagnostic interpretation of images acquired from ct, mr, cr, dr, us, xa and other dicom-compliant medical imaging systems when installed on suitable commercial-standard pc hardware. ca1000 is intended for use as a primary diagnostic and analysis workstation in radiology/cardiology or other departments. it is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger pacs configuration. aw suite is a third-party application that interfaces with ca1000. at the heart of aw suite is the volume viewer. this allows you to process, review and analyze 3d reconstructed images originally acquired from ct, mr, x-ray angio, nm and pet scanning devices. the combination of acquired images, reconstructed images, annotations and measurements provides you with clinically relevant information for diagnosis, surgery and treatment planning.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - cardiosoft is a pc-based system for electrocardiographic (resting ecgs, exercise tests) and spirometric tests as well as for ambulatory blood-pressure examinations. the program is intended for use under the direct supervision of a health-care practitioner. cardiosoft uses an analysis program which can be used as a tool in interpreting ecg waveforms.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - the compact airway module, e-caiovx family (e-caio, e-caiov, e-caiovx, e-co, e-cov and e-covx) is indicated for monitoring hospital patients respiration (co2, 02, n20, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (oxygen consumption vo2, carbon dioxide production vco2, respiratory quotient rq, and energy expenditure, ee). gas exchange status monitoring is not indicated in the presence of n20+02 mixtures.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - neurology - the eeg module and the eeg headbox are indicated for monitoring of electroencephalograph (eeg), frontal electromyograph (femg) and auditory evoked potentials (aep) of all hospital patients.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - indicated for monitoring co2 and respiration rate of all hospital patients weighing more than 5kg (11 ibs.).

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - the s/5 anesthesia monitor with l-ane07 or lane07a software is intended for multiparameter patient monitoring with optional patient care documentation. the s/5 anesthesia monitor with l-ane07 and l-ane07a software is indicated for monitoring of hemodynamic (including arrhythmia and st-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, entropy (state entropy and response entropy) and neurophysiological status of all hospital patients. when the bis module is used with the s/5 anesthesia monitor with l-ane07 and l-ane07a, it is intended for use by personnel trained in its proper use. it is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of eeg signals. the bispectral index (bis), a processed eeg variable, and one component of the bis module, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. the s/5 anesthesia monitor with l-

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. it provides uninterrupted monitoring of physiological patient data. it is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous po2 and pco2, co2 and respiratory mechanics. it is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, o2, impedance cardiography, electroencephalography and bispectral index. the solar 8000i patient monitoring system also provides physiological data over the unity network.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 3500 ecg analysis system is intended to acquire, analyze, display and record testing electrocardiographic information from adult and pediatric populations. basic systems deliver 3,6,12 or 15 lead ecgs, including interpretive analysis. transmission and reception of ecg data to and from a central ecg cardiovascular information system is optional. the mac 3500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.