Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the discovery nm 750b gamma camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. the resultant images are intended to be reviewed by qualified medical professionals. the discovery nm 750b gamma camera is intended for diagnostic imaging of the breast and other small body parts. the discovery nm 750b gamma camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population).

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the discovery nm/ct 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. the system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the discovery nm/ct 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. the system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. the lung cancer screening option for qualified ge ct systems is indicated for using low-dose ct for lung cancer screening. the screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or professional medical society.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the dpx bone densitometer is intended to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended for use by nuclear medicine (nm) or radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of nmi data, including planar scans (static, whole body, dynamic, multi-gated) and tomographic scans (spect, gated spect, dedicated pet or camera-based-pet) acquired by gamma cameras or pet scanners. the system can run on a dedicated workstation or a server-client configuration. the nm or pet data can be coupled with registered and/or fused ct or mr scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. refer to xeleris 4.0 operator guide for indications of datquant, q.lung, q.brain and alcyone cfr applications.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - 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.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the logiq diagnostic ultrasound system is intended for use by a qualified physician for ultrasound evaluation. specific clinical applications and exam types include: • fetal/obstetrics • abdominal (including gyn) • pediatric/neonatal • small organ (including breast, testes, thyroid) • basic cardiac (not available for ge logiq c2) • vascular • urology (including prostate)

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the logiq f series are general purpose ultrasound imaging and analysis systems providing digital acquisition, processing and display capability, clinical applications including: abdominal, obstetrical, gynecological, small parts, vascular/ peripheral vascular, transcranial, pediatric musculoskeletal, urological, cardiac, transvaginal, and biopsy. transrectal application is only applicable for logiq f8 expert / logiq f8 / logiq f6 with software version r2.0.4 and above

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the idxa bone densitometer is intended to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac1600 is intended to acquire, analyze, display and record information from adult and pediatric populations. pediatric population is defined as patients between the ages of 0 and 15 years. the mac1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ecg signals from surface electrodes. the mac1600 is used under the direct supervision of a licensed healthcare practitioner. the mac 1600 is not designed to provide alarms for arrhythmia detection. the device is not suitable for intra cardiac application. it is not intended for use as a vital signs physiological monitor or for use during patient transport.