Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - case cardiac testing system is intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. the case cardiac testing system is designed to acquire process, record, archive, analyze and output (12 and 15 lead) ecg data during a period of physiologic stress or during a resting ecg test, acquire data from ancillary devices (such as spirometry and ambulatory blood pressure), provide median morphology recordings and record ecg in real-time with and without arrhythmia detection. the arrhythmia detection portion of case cardiac testing system is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.

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

ge healthcare australia pty ltd - 38473 - information system, patient record - information system for patient records

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

ge healthcare australia pty ltd - 44098 - information system software, application program, cardiology - this device is a cardiology information system whichis intended to store, access and manage cardiovascular information on adult and pediatric patients. the information consists of measurements, text, and digitized waveforms. this cardiology information system is intended to provide the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ecg serial comparison and interpretive 12-lead analysis. this device is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. this cardiology information system is not intended for real-time patient monitoring or for pediatric serial comparison.

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

ge healthcare australia pty ltd - 17222 - information system, - this medical device may be intended to collect, store, manipulate, retrieve and output, e.g. print or display, information.

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

ge healthcare australia pty ltd - 38473 - information system, patient record - this medical device may be intended for the purpose of electronic registration and storage of patient data.

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

ge healthcare australia pty ltd - 38473 - information system, patient record - this system is intended for the electronic registration and storage of patient data, which can be collected from inter-connected medical devices, eg patient monitoring devices, but which may also be inut manually by clinical staff. such systems can present this kind of information as graphic display, trends, laboratory results, patient administration data, and notes. it is a specially designed data program application which is usually supplied for installation in existing mainframe or decentralized computers or a computer network.

Australia - English - 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.

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

ge healthcare australia pty ltd - 44101 - information system software, application program, bedside - the carescape gateway device is intended to provide outbound data to systems that are not components of the carescape network mc or s5 network. the carescape gateway provides near real-time streaming data in an xml format for vital sign data and waveforms from patient monitoring systems. the carescape gateway also provides outbound vital sign data in an hl7 format from patient monitoring systems. the carescape gateway provides adt inbound information to minimize incorrect data entry. carescape gateway also relays time adjustments from an ntp (network time protocol) time source to the carescape network time master to synchronize the clocks on carescape network devices. the carescape gateway is intended to electronically transfer data to and from medical devices. however, it is not intended to control any monitoring functions of the monitoring devices to which it connects, nor is it intended to be used in the monitoring of patients connected to said devices. the carescape gateway operates unattended and is not located near the patient or caregiver. the typical ?user? is an information system or application that resides outside of the monitoring network that needs this data (e.g., a cis system). the carescape gateway has no clinical user interface; the only user-interface is web-based and intended for administrators of the device.

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

ge healthcare australia pty ltd - 44101 - information system software, application program, bedside - the portrait core services (portrait css01) are a set of software services that enable the communication and interaction of the portrait mobile monitoring solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. the portrait core services can transmit patient physiological trends and numerics (ihe pcd dec) and alarm events (ihe pcd acm) outbound. the portrait core services can also receive hl7 adt information to admit patients to the portrait mobile monitoring solution.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - physical medicine - ge t-2100 treadmill is intended for use with any of the several ge medical systems information technologies exercise testing systems or the mtc-1 (manual treadmill controller), for administering a controlled exercise load during a diagnostic stress test.