Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 63386 - x-ray image interpretive software - the chest x-ray product, qxr analyses all chest radiographs that meets the inclusion criteria. qxr detects suspected abnormalities in the chest x-ray and localizes them and primarily provides clinically relevant tags. additionally, the software has the capability to provide position of the suspected abnormalities, if relevant. the results produced by qxr is intended to be used to support certified radiologists or other licensed medical practitioner for clinical decision making. it is a support tool to assist the clinician (radiologist) used with original radiographs to improve efficiency, accuracy and turnaround time and is not to be used as a source of medical advice or determine treatment plan or recommend a course of action for the patient.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 57793 - public respirator, single-use - the device is a non-powered air-purifying respirator which can provide protection against particles including dust, smoke, fog and microbes.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 35177 - mask, surgical, single use - the tenamyd/ tenami medical face masks are intended to be worn by the general public or healthcare personnel. the mask covers the user's nose and mouth to protect the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment. the mask is a disposable, single-use device.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 57812 - radiology dicom image processing application software - us2.v1 is a software platform that automatically processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, producing a full report with measurements of several key cardiac structural and functional parameters. the data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making based on dicom images produced by fda approved ultrasound devices. us2.v1 is indicated for use in adult patients. us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).

Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 44138 - ultrasonic lithotripsy system transducer, single-use - the coronary intravascular lithotripsy catheter consists of a standard percutaneous transluminal coronary angioplasty balloon catheter with integrated lithotripsy emitters. the application of lithotripsy mechanical pulse waves alters the structure of calcified vascular deposit (stenosis) prior to low pressure balloon dilation of the stenosis and facilitates the passage of blood and enhances placement of a stent. the catheter is intended to be used with a proprietary generator. the shockwave c2 coronary ivl system is indicated for lithotripsy-enhanced, lowpressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 62980 - balance-training tongue electrical stimulation system - the pons device is a non-implantable neurostimulator intended for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. pons is not intended to be used alone without an exercise program.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 44138 - ultrasonic lithotripsy system transducer, single-use - the shockwave s4 peripheral ivl system is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries, in patients who are candidates for percutaneous therapy. not for use in the coronary, cerebral, aortic, or common iliac vasculature.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 45023 - dressing, occlusive, collagen - myriad matrix? is a collagen matrix with an intact extracellular matrix (ecm). derived from ovine (sheep) forestomach tissue, this advanced matrix is non-reconstituted collagen, thus it retains the innate biological structure and function of the native ecm associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. myriad matrix is intended to cover, protect, and provide a moist wound environment.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 63386 - x-ray image interpretive software - the screenpoint transpara? system is intended for use as a concurrent reading aid for radiologists during interpretation of 2d and 3d mammograms of asymptomatic women to identify regions suspicious for breast cancer. output of the device contains region-based scores indicating the likelihood that cancer is present in specific regions and an overall score indicating the likelihood that cancer is present on the mammogram. patient management decisions should not be made solely on the basis of analysis by transpara?.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 34017 - sternal fixation system - the device is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion.