Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac1600 is intended to acquire, analyze, display and record information from adult and pediatric populations. pediatric population is defined as patients between the ages of 0 and 15 years. the mac1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ecg signals from surface electrodes. the mac1600 is used under the direct supervision of a licensed healthcare practitioner. the mac 1600 is not designed to provide alarms for arrhythmia detection. the device is not suitable for intra cardiac application. it is not intended for use as a vital signs physiological monitor or for use during patient transport.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac400 is used under the direct supervision of a licensed healthcare practitioner. trained operators in small and medium hospitals will use the mac 400 to record ecg signals from surface electrodes. the mac400 is intended to acquire, measure, display and record information from adult and pediatric populations. the basic system delivers 3 channels in automatic mode and 1 or 3 channels in manual mode. the arrhythmia detection portion of the mac400 is provided to the customer for the convenience of automatic documentation. it is not designed to provide alarms for arrhythmia detection. it is not intended for use as a vital signs physiological monitor. the mac400 is not intended for use during patient transport.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 800 resting ecg analysis system is a portable ecg acquisition, analysis and recording system intended to: acquire, analyze, display, and record information from adult and pediatric populations; be used under the direct supervision of a licensed health care practitioner;be used by trained operators in a hospital or medical professional’s facility environment, as well as used in clinics, physician offices, outreach centers;offer two basic modes of operation: (1) resting ecg mode and (2) arrhythmia mode; print 3- and 6 leads of ecg; be upgradeable to provide software options such as 12-lead ecg measurement and interpretive analysis, provide for the optional transmission and reception of ecg data to and from a central ecg cardiovascular information system.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - mac 1200 is an ecg acquisition and recording system with a built-in printer and graphics display. the intended use of this device is for data acquisition and recording for resting ecg and stress testing ecg and for recording ecg in real time with arrhythmia detection. it supports the operation modes:12 lead mode; 6 lead mode, arrhythmia mode. optionally it provides measurement and interpretation of the 10-second resting ecgs. it is intended to be used by trained operators under direct physician supervision when ecg records are required. it is suitable for intracardiac application. it is designed as a portable device.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - system is intended to produce cross-sectional body images by computer reconstruction of x-ray transmission data at different angles & planes, including axial, cine, helical (volumetric), cardiac & gated acquisitions, with or without contrast. device may include signal analysis & display equipment, patient & equipment supports, components & accessories, data & image processing to produce images in trans-axial & reformatted planes. images can be post processed to produce additional imaging planes/analysis results. system is indicated for head, whole body, cardiac & vascular x-ray ct applications in patients of all ages. device output is used for diagnosis of disease,trauma,or abnormality & for planning, guiding & monitoring therapy. system is indicated for using low-dose ct for lung cancer screening. screening must be performed within the established inclusion criteria of programs/protocols that have been approved & published by either a governmental body or professional medical society.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the systems are whole body magnetic resonance scanners 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 system 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 - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the signa artist is a whole body magnetic resonance scanners 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 signa artist reflects 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 - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - the tram module is intended to provide uninterrupted monitoring of physiological parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. during non-transport monitoring, the tram module functions in the bedside monitoring system. physiological parameter data includes ecg, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. the tram module acquires, process and stores information regarding these parameters. the tram module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. intended for professional medical facility in multiple areas such as operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care or neonatal intensive care. the device is intended for use as

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the transport pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. when used with the patient data module (pdm) or the tram acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. physiological parameter data includes ecg, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature and respiration. both the pdm and tram acquisition module acquire, process and store information for all aforementioned parameters.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the venue is a general-purpose diagnostic ultrasound system for use by qualified healthcare professionals. the clinical environments where the venue can be used include critical care and emergency room environments, as well as point-of-care areas in offices, clinical and hospital settings for diagnosis of patients. the venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: • abdominal (including gynecology and urology) • thoracic/pleural • ophthalmic • fetal/obstetrics • small organ (including breast, testes, thyroid) • peripheral vascular • adult and neonatal cephalic • pediatric • musculoskeletal (conventional and superficial) • cardiac (adults and pediatric) • transesophageal (tee) • transrectal • transvaginal • imaging guidance of interventional procedures (e.g. nerve block, vascular access)