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

varian medical systems australasia pty ltd - 38138 - collimator, accelerator system, motorized, automatic aperture control - 050112-webe-68k7cn a motorized beam limiting device assembly, i.e. collimator assembly whose jaw or leaf positioning functions are under computer control. mounted at the beam exit port of an accelerator system housing.radiotherapy treatment

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

canon medical systems anz pty ltd - 58473 - diagnostic digital imaging system workstation application software - this software is used in combination with a diagnostic x-ray system to provide the image information and measurement results required to support interventional radiography (ivr) procedures such as percutaneous coronary intervention (pci) and embolization.

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

aro systems pty ltd - 44105 - information system software, application program, physician practice management - radiology information system for optimising the radiology workflow. to administer patient data, document patient visits and performed studies, the related findings, documents, diagnoses, as well as the liquidation of the rendered services. it is further possible to create and print automatically generated reports in word processing programs.

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

k2 medical systems pty ltd - 36230 - information system, obstetrical - k2ms guardian is intended for use in the labour ward of hospital maternity units. it is intended to capture and store a record of labour episodes using fetal heart recording equipment to capture the fetal heart rate data. it will also allow the staff of the labour ward to view and monitor the status of a case from within, and external to, the delivery room. the system is not intended to automate fetal monitoring, reduce contact time with patients or deskill clinicians.

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

canon medical systems anz pty ltd - 37654 - mri system, full-body, superconducting magnet - the mri system is indicated for use as a diagnostic imaging modality that produces cross- sectional transaxial, coronal, sagittal and oblique images that display anatomic structures of the head and body.

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

varian medical systems australasia pty ltd - 46467 - patient positioning system, implanted-markers - a system designed to be used in conjunction with implantable markers to track and visualise the movement of tumors in radiation therapy

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

aro systems pty ltd - 35719 - picture archiving and communication system, radiology - dicom software application for the archiving of medical images (pacs - picture archiving and communication system). to archive, send, receive and display data from dicom compliant modalities and other sources, to forward it to dicom compliant modalities and to administer the data.

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

varian medical systems australasia pty ltd - 40887 - radiation therapy treatment planning system, application program software - a dedicated information system comprising computers and software using diagnostic images, e.g. x-ray, ct, mri, or 2 or 3-d images of the patient obtained during virtual simulation with a therapy simulation system, and/or data associated with a specific radiation therapy treatment modality. radiotherapy treatment

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

varian medical systems australasia pty ltd - 36056 - radiation therapy treatment system, record/verify - dv-20050504-da-003344-1 a dedicated information system comprising computers and software intended to reduce human error by monitoring linear accelerator parameters to verify that the proper radiotherapy treatment is being delivered, and to provide a permanent record. radiotherapy treatment

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

varian medical systems australasia pty ltd - 38300 - radionuclide system, therapeutic, brachytherapy, remote afterloading - dv-20050504-da-003346-1 a system using a remotely controlled radioactive source transport system to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. brachytherapy treatment