Singapore - English - 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 - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - the hemodynamics modules are indicated for the monitoring of hemodynamic parameters of all hospital patients. the hemodynamic parameters of the module comprise ecg including st-segment and arrhythmia, impedence respiration, nibp, temperature, spo2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure. impedence respiration measurement is indicated for patients aged 3 and up. the nibp measurement is indicated for patients who weigh 5kg (11lb.) and up. the device is indicated for use by qualified medical personnel only.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - mammoworkstation is designed to assist radiologists in conducting primary diagnostic interpretation for diagnostic and screening mammography through flexible and interactive manipulation of multimodality softcopy images. mammoworkstation provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment. mammoworkstation is designed to give easy and economic access to and display of multimodality softcopy images, structured reports, and cad results through interfaces to various image storage devices using dicom or similar interface standards. mammoworkstation supports the creation of structured reports according to the dicom breast imaging report templates. mammoworkstation supports teleradiology and teleconferencing providing access to multimodality softcopy images and structured reports in multiple locations within and outside the hospital.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. it is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by an attending physician: • assist/control (pressure controlled or volume controlled) • simv (pressure controlled or volume controlled) • cpap/psv suitable for use in the icu and all other hospital areas, in all hospital-type facilities,alternate care sites, transport,emergency and in the home environment. the non-invasive pulse oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate, suitable for use in all above mentioned areas,excluding mr environments. it is a restricted device intended for use by qualified, trained personnel under physician supervision.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - the intended use of the ivent101 ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. the intended patient population includes infants from 5 kg through adult patients. the ivent10 ventilator is suitable for use in institution, home and portable settings. the ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. indications the ivent101 is capable of providing the following types of ventilatory support: • assist/control and simv with either volume, pressure, or pressure regulated volume control (prvc) • cpap with pressure support • adaptive bi-level for either niv or invasive ventilation.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended for use by a qualified physician for ultrasound evaluation of fetal/ob; abdominal (including gyn, pelvic and infertility monitoring/follicle development); pediatric; small organ (breast, testes, thyroid etc.); neonatal and adult cephalic; cardiac (adult and pediatric); musculo-skeletal conventional and superficial; peripheral vascular; transvaginal (tv); transrectal (tr); and lntraoperative (abdominal, pv and neurological).

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the logiq v2/logiq v1 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: fetal/ob; gyn; abdominal; pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiac (adult & pediatric); peripheral vascular; musculoskeletal conventional & superficial; urology; transrectal; transvaginal; imaging guidance of interventional procedures (e.g nerve block; vascular access; tissue biopsy/fluid drainage).

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 600 resting ecg analysis system is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations. basic systems deliver 3 or 12 lead ecgs, and can be upgraded to provide software analysis options such as interpretive analysis of the electrocardiogram. transmission of ecg data to a central ecg cardiovascular information system is optional. the mac 600 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.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the system is intended to be a high-performance, multichannel resting electrocardiograph. as a resting electrocardiograph, the system simultaneously acquires data from each lead. once the data is acquired, it can be analyzed, reviewed, stored, printed, or transmitted. it is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size. the system 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.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac-lab 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, 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).