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 -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

ge international inc, tanzania - corometrics 170 series,corometrics 250 series fetal monitors -

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the air anterior array is a receive-only rf coil designed for use with ge 3.0t mri systems. when used with other coils, the indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular, and long bone imaging. the 1.5t air anterior array (aa) is a receive-only rf coil designed for use with ge 1.5t mri systems to produce diagnostic images of general human anatomy, including extremities. the air posterior array is a receive-only rf coil designed for use with ge 3.0t mri systems. the indications for use include spine. when used with other coils, the indications for use also include abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging. the nucleus detected is hydrogen for all coils.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - 4d view is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of 3d/4d ultrasound images. 4d view provides the user the ability to display and edit 3d/4d ultrasound images that have been created in certain ge proprietary formats. 4d view is designed to accept, transfer, display, store and process these specific medical data, and enables the user to measure and annotate the images. the medical images, which 4d view displays to the user, can be used for diagnostic purposes. 4d view is intended for professional use only. 4d view is not intended to be used as an automated diagnosis system. 4d view is not intended to operate medical devices in surgery related procedures.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - image display of ge ultrasound 3d/4d data sets for diagnostic purposes including measurements on displayed image.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - anaesthesiology - the capnostat / capnoflex lf co2 system is intended for continuous, non-invasive measurement of the carbon dioxide concentration and respiration rate of adult, pediatric or neonatal patients to a ge medical systems information technologies' host monitoring system.