सिंगापुर - अंग्रेज़ी - 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.

सिंगापुर - अंग्रेज़ी - 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.

सिंगापुर - अंग्रेज़ी - 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,

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - the patient side module and accessories 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, impedance respiration (for patients aged 3 and up), nibp (for patients who weigh 5kg and up), temperature, spo2 (including monitoring during conditions of clinical patient motion). impedance respiration measurement is indicated for patients aged 3 and up. the patient side module (model family e-psm(p)) is also indicated for invasive blood pressure.

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the angiographic x-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. additionally, with the or table, the angiographic x-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. the or table is suitable for interventional and surgical procedures.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 31072 - bag, medical device, single use - the portrait mobile patient monitor pouch (portrait mmp01) is an optional accessory intended to enable the portrait mobile patient monitor to be carried while the patient is ambulatory. the portrait mobile patient monitor pouch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

सिंगापुर - अंग्रेज़ी - 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.

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the web viewer displays information received from other networked devices. it is comprised of a mobile care server and web viewer clients. the mobile care server maintains and coordinates the network connections between the devices in the datex-ohmeda and unity networks and web viewer clients. the web viewer client runs on a generic computer that is connected to the hospital local area network (lan). the web viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. the web viewer can be used for patients in hospital and it is meant for consultation and remote monitoring use. the web viewer is not a primary alarm source. the device is for use by qualified medical personnel only.

सिंगापुर - अंग्रेज़ी - 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.

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - viewpoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound. viewpoint 6 provides the user the ability to include images, drawings, and charts into medical reports. viewpoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. the medical images, which viewpoint 6 displays to the user, can be used for diagnostic purposes. viewpoint 6 is intended for professional use only. viewpoint 6 is not intended to be used as an automated diagnosis system. viewpoint 6 is not intended to operate medical devices in surgery related procedures.