Device Dossier

Information system software, application program, cardiology

Device Dossier for Information system software, application program, cardiology (Information system software, application program, cardiology, Class IIa,…

Intended purpose

Cordiana Dx16 is a software system used for reference and diagnostic viewing, manual editing and printing of cardiopulmonary records, consisting of measurements, text and digitized waveforms, with associated reports and documents. Users do not need to download or install any additional software or plug-ins to use the zero-footprint browser client. Cordiana Dx16 provides authenticated users the ability to search for, list, display, edit and confirm cardiopulmonary studies through the use of reviewing, onscreen measuring and editing tools. Cordiana Dx16 is intended for use by healthcare professionals, including (but not limited to) physicians, nurses and medical technicians, trained on the use of the software. Cordiana Dx16 is intended to be used in hospitals or facilities providing patient care, where cardiopulmonary studies are stored in a remote storage system, such as a Picture Archive and Communication System (PACS), with which records, reports and documents can be queried, retrieved and stored using DICOM or similar interface standards. Cordiana Dx16 does not provide storage of records or associated reports and documents, does not modify the original record and waveform information, and is not intended for real-time monitoring.

TGA Public Summary