Austrālija - angļu - 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.

Singapūra - angļu - HSA (Health Sciences Authority)

alvimedica singapore pte ltd - cardiovascular - alvision™ interventional cardiology diagnostic catheters are intended for use in the delivery of radio-opaque media to selected sites in the coronary vascular system.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

fujifilm australia pty ltd - 18119 - information system, cardiology - epiphany cardio server is a cardiology information system designed for the collection and management of electrocardiography data (ecg, stress, holter, etc.). the device is designed for use by clinicians of cardiology practices, hospitals and university medical medical centres to analyze and report on patient electrocardiography reports.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

intervene medical pty ltd - 18119 - information system, cardiology - an information system designed to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. it is a specially designed data program application (software) which is usually supplied for installation in existing mainframe or decentralized computers or a computer network.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

agfa healthcare australia - 18119 - information system, cardiology - cardioreport xp suite is an application that is designed to electronically receive, collect, store, manage, display, output, and distribute data and reports within or between healthcare facilities to support the administrative and clinical activities associated with the provision and utilisation of cardiology services and facilities.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 18119 - information system, cardiology - an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources. the device is intended for use in the cardiology, radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger pacs configuration. the device offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting. the device is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 47699 - cardiac electrophysiology application software - the cardiologs platform (also known as cardiologs ecg analysis platform) is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ecg data in subjects over 18 years of age. the product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as holter, event recorder, 12 lead ambulatory ecg devices, or other similar devices for the assessment the heart rhythm. the cardiologs platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ecg systems, such as an ecg management system. the cardiologs platform provides ecg signal processing and analysis, qrs and ventricular ectopic beat detection, qrs feature extraction, interval measurement, heart rate measurement, and rhythm analysis. the cardiologs platform is not for use in life supporting or sustaining systems or ecg monitor and alarm devices. the product can be integrated into computerized ecg monitoring devices. in this case, the medical device manufacturer will identify the indication for use depending on the application of their device. cardiologs platform interpretation results are not intended to be the sole means of diagnosis. it is offered to physicians and clinicians on an advisory basis only in conjunction with the physician?s knowledge of ecg patterns, patient background, clinical history, symptoms, and other diagnostic information.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 44098 - information system software, application program, cardiology - non measuring application for medical data communication.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 44098 - information system software, application program, cardiology - the product is a computer system, used within a clinical network, which is intended to be used by trained professionals. it provides the ability to retrieve, store, edit, send and print ecgs and related digitized clinical documents through the use of on-screen measurement and editing tools. the system receives files (such as ecg, stress, or holter) from any compatible device, displaying such data to the clinician for analysis and review. the product does not modify the original ecg waveform and does not provide an automated ecg analysis.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 44098 - information system software, application program, cardiology - the muse nx cardiology information system is intended to store, access and manage cardiovascular information on adult and pediatric patients. the information consists of measurements, text, and digitized waveforms. the muse nx cardiology information system provides 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. the muse nx cardiology information system 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.