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 - the dr-f is a medical diagnostic radiography system. it is intended to generate radiographic images of human anatomy. it is applicable for all the patients who need any of these general purpose diagnostic procedures. this device is not intended for mammographic and dental applications.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 47487 - medical device electrical cable, general purpose - a non-patient-contact, insulated, electrical cord with a connector (plug) at both ends is intended to to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). it is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. some types may include an electrical isolator to prevent electrical shocks. this is a reusable device.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 60723 - medical image management system - this device is intended to be used in medical practices and in clinical departments and serves the purposes of electronic documentation (recording) and storage of examinations in the form of text and images. it is intended for professional use only. it is designed to accept, transfer, display, store and process medical images and data, and can measure, calculate, annotate, prepare and print patient examination reports primarily for diagnostic ultrasound. the ultrasound and endoscopy images which this device displays to the user can be used for diagnostic purposes. for all other kinds of image data, such as x-ray or ct, this device can only be used for documentation and training purposes. this device is not intended to be used as an automated diagnosis system.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 60723 - medical image management system - this device 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. it provides the user the ability to including images, drawings, and charts into medical reports. it 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 this device displays to the user, can be used for diagnostic purposes. it is intended for professional use only. this device 6 is not intended to be used as an automated diagnosis system. this device is not intended to operate medical devices in surgery related procedures.

Singapore - engelsk - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the prodigy 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 prodigy 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 - senographe systems: ds and essential the senographe system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. it generates digital mammographic images which can be used for screening and diagnosis of breast cancer. senographe stereotaxy: ds stereotaxy and essential stereotaxy. senographe stereotaxy is an optional accessory for the senographe full field digital system. it is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. it is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices).

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 47487 - medical device electrical cable, general purpose - this device is intended to provide a connection between two or more devices for the purpose of transmitting an energy that may, or may not, contain information.

Hviterussland - russisk - Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

ge hangwei medical systems co. ltd., КИТАЙ -