Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - vscan with dual probe is general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. with a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications: cardiac; abdominal; renal; ob/gyn; urology; fetal, evaluation of presence of fluid; peripheral vascular imaging (e.g. lower extremity, carotid); procedure guidance for arterial or venous vessels (e.g. central lines, upper extremity); imaging guidance for needle/catheter placement (e.g. paracentesis, thoracentesis, amniocentesis); thoracic/lung (e.g. pleural motion/sliding, line artifacts); thyroid and other small organs; long bone; hip and knee joints; and pediatrics.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - universal viewer is a software application that displays medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. it performs operations relating to the transfer, storage, display, and measurement of image data. typical users of this system are authorized healthcare professionals. mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. lossy compressed mammographic images and digitized film screen images should not be reviewed for primary image interpretations with use of the universal viewer.

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

ge healthcare pte. ltd. - general hospital - portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. intended for use under the direct supervision of a licensed health care practitioner. not intended for use during mri. monitor can be a stand-alone monitor or interfaced to other devices via network. the monitors and displays: ecg, invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure functional oxygen saturation (spo2) and pulse rate via continuous monitoring(including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring esophageal/nasopharyngeal/tympanic/rectal/bladder/axillary/skin/airway/room/myocardial/ core/surface temperature, impedance respiration, respiration rate, airway gases, c.o. and entrophy.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - intended for use on adult, pediatric & neonatal patients. one patient at a time. for monitoring of: • hemodynamic (incl. ecg, st segment, arrhythmia detection, ecg diagnostic analysis & measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution & pulse contour), temperature, mixed venous oxygen saturation, central venous oxygen saturation, & surgical pleth index), • respiratory (impedance respiration, airway gases (co2, o2, n2o, and anesthetic agents), spirometry, gas exchange), • neurophysiological status (incl. electroencephalography, entropy, bispectral index, and neuromuscular transmission). intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - to receive medical images (including mammograms) from various imaging sources. images and data can be stored, communicated, processed and displayed in the local system or across computer networks at distributed locations. lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. mammographic images may only be interpreted using an fda approved monitor that offers at least 5 mpixel resolution and meets other technical specifications reviewed and accepted by fda.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - general hospital - for use under direct supervision of a licensed healthcare practitioner. device is a portable multi parameter unit designed for monitoring adult,pediatric and neonate patient vital signs in hospital subacute care environments,such as same-day surgery,emergency rooms,recovery/pacu,progressive care,interventional radiology,special care units and gi/endoscopy. it monitors and displays oscillometric non-invasive blood pressure (systolic,diastolic and mean arterial pressure),heart/pulse rate,respiration rate,ecg,temperature with an reusable electronic thermometer (predictive mode for oral and rectal temperature measurement,monitor mode for auxiliary temperature measurement) and functional spo2 and pulse rate via spot checking and continuous monitoring,including monitoring during conditions of clinical patient motion or low perfusion. it detects alarm limit conditions and capable of recording up to two waveform.clinician can view,record and recall data derived from each parameter.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - centricity pacs software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices. the centricity pacs workstation software is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. it is also intended for use as a clinical review workstation throughout the healthcare facility.

Singapore - engelsk - 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 - engelsk - 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.