Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the datex-ohmeda network and icentral (including icentral client) transfers information between networked datex-ohmeda devices in the monitor network as well as between monitor network and networked devices in ge unity network™. it also allows information transfer between several icentrals. the icentral maintains the network connections between the datex-ohmeda bedside monitors and other networked devices in monitor network. the icentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. the icentral client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. the datex-ohmeda network will be used for patients in the hospital and it is meant for continuous use.

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. - 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.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 5500hd ecg analysis system is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. basic systems deliver 3, 6, 12, or 15 lead ecg’s, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of qrs and p wave portions of the electrocardiogram. transmission and reception of ecg data to and from a central ecg cardiovascular information system is optional. the mac 5500hd 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. - radiology / imaging - the ge optima mr450w 1.5t system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. the mr450w system 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 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 system 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. the gem option for i.5t mri systems is a set of receive-only rf surface coils designed for use with l.5t mri systems manufactured by ge healthcare. the gem option for i.5t mri systems is indicated for use for: head,

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

ge international inc, tanzania - infant warmer -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

ge international inc, tanzania - navigator application suite -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

ge international inc, tanzania - carescape one patient monitor -

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.