Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the ge oec fluorostar 7900 mobile radiology system is intended for use on human beings. regulations on its use cover the areas of fluroscopy and radiology in diagnostic and surgical applications. the range of applications includes urology, endoscopy, orthopedics, angiography, cardiological, vascular and neurological applications and applications in intensive care and a&e. it is suitable for daily use in a clinical environment by various users.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the ge optima ct520 computed tomography x-ray 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, patient for all ages, including axial, cine, helical, 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 ge optima ct520 ct scanner system is indicated for head, whole body, cardiac and vascular x-ray computed tomography applications. the device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the ge revolution act ct scanner system is indicated to be used for head, whole body and vascular x-ray computed tomography applications.

Singapore - English - 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.

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. - radiology / imaging - the signa pet/mr system combines magnetic resonance diagnostic devices (mrdd) and positron emissions tomography (pet) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. the combined system maintains independent functionality of the mr and pet devices, allowing for single modality mr and / or pet imaging. these systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. clinical data includes: ecg waveforms, heart rate, pulse oximetry (spo2), respiration rate, co2 (etco2), temperature, hemodynamic measures (for example, valve gradients and areas, cardiac output, shunts, invasive and noninvasive blood pressure).

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the vivid i / vivid q ultrasound unit is intended for the following applications: • abdominal • cardiac • musculoskeletal including superficial • small organ • pediatric • fetal heart • transesophageal • peripheral vascular • neonatal cephalic • adult cephalic • intraoperative

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the vivid s5/vivid s6 ultrasound unit is intended for the following applications: • abdominal • cardiac • musculoskeletal including superficial • small organ • pediatric • ob/gyn • fetal heart • transesophageal • peripheral vascular • neonatal cephalic • adult cephalic • intraoperative