Singapura - Inggris - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - centricity* cardio imaging is a software only picture archiving and communication system (pacs) medical device. it will be sold as a software only device to operate on general purpose computing hardware. centricity* cardio imaging receives medical images and other information from various data sources. information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. centricity* cardio imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. these trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses and technicians. it is not intended for use in the patient vicinity.

Singapura - Inggris - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - medical diagnostic digital radiography system brivo xr575 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.

Tanzania - Inggris - Tanzania Medicinces & Medical Devices Authority

ge international inc, tanzania - infant warmer -

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

ge healthcare iits australia pty ltd - 60723 - medical image management system - this device is intended to display medical images and data from various imaging sources, and from other healthcare information sources. medical images and data can be displayed, communicated, stored, and processed. typical users of this system are authorized healthcare professionals. the device is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

Australia - Inggris - 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 - Inggris - 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 - Inggris - 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.

Singapura - Inggris - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - brivo xr118 digital x-ray imaging system should be used in combination with conventional x-ray imaging system to generate a digital image.

Singapura - Inggris - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended to be used for head, whole body computed tomography applications. the 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, including axial, cine, helical (volumetric), 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 system is indicated for head, whole body, cardiac and vascular x-ray computed tomography applications in patients of all ages.

Singapura - Inggris - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended to be used for head, whole body computed tomography applications. the 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, including axial, cine, helical (volumetric), 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 system is indicated for head, whole body, cardiac and vascular x-ray computed tomography applications in patients of all ages.