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

acra regulatory services pty ltd - 35750 - cable/lead, electromyograph - the disposable stimulation clip is intended to be used for the conduction of electrical signals, in combination with recording/stimulating equipment

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

acra regulatory services pty ltd - 40749 - coil, mri, radio frequency - the head coil/surface coil is intended to be used for diagnostic imaging/ spectroscopy with a mr system (mri, mrs)

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

acra regulatory services pty ltd - 45138 - basic male condom, hevea-latex - for contraception and prevention of sexually transmitted infections

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

acra regulatory services pty ltd - 61779 - thrombectomy wire-net - sterile invasive thrombectomy system is indicated for: * the non-surgical removal of emboli and thrombi from blood vessels. * injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. the clottriever thrombectomy system is intended for use in the peripheral vasculature, intended for use in deep vein thrombosis (dvt) treatment.

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

acra regulatory services pty ltd - 33519 - suture retention device - suture retention device intended to be used for temporary suture retention following a percutaneous venous procedure

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

acra regulatory services pty ltd - 35071 - filter, blood transfusion - sterile invasive blood transfusion filter is used with triever catheters for autologous blood transfusion.

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

acra regulatory services pty ltd - 66423 - thrombectomy wire-net introduction set - sterile invasive thrombectomy wire-net introduction sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature and to minimize blood loss associated with such insertions.

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

acra regulatory services pty ltd - 57812 - radiology dicom image processing application software - cina is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-enhanced head ct images and (2) ct angiography of the head.

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

acra regulatory services pty ltd - 61779 - thrombectomy wire-net - sterile thrombectomy system is indicated for: - the non-surgical removal of thrombi and emboli from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. - injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft. the thrombectomy system is intended for use in the peripheral vasculature. the thrombectomy system is not intended for use in deep vein thrombosis (dvt) treatment.

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

acra regulatory services pty ltd - 57812 - radiology dicom image processing application software - cina chest is a radiological computer aided triage and notification software indicated for use in the analysis of chest and thoraco-abdominal ct angiography. the device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) chest ct angiography for pulmonary embolism (pe) and (2) chest or thoraco-abdominal ct angiography for aortic dissection (ad). cina chest uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) pe or (2) ad on a standalone web application in parallel to the ongoing standard of care image interpretation. the user is presented with notifications for cases with suspected pe or ad findings. notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. the device does not alter the original medical image, and it is not intended to be used as a diagnostic device. the results of cina chest are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. notified clinicians are ultimately responsible for reviewing full images per the standard of care.