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

acra regulatory services pty ltd - 57812 - radiology dicom image processing application software - briefcase is a radiological computer aided triage and notification software indicated for use in the analysis of radiological images. the device is intended to assist hospital networks and trained medical specialists in workflow triage by flagging and communication of suspected positive findings the following indications: 1.intracranial hemorrhage (ich) triage, non-enhanced head ct. 2.cervical spine fracture (csf) triage, non-enhanced cervical spine ct, bone kernel only. 3.pulmonary embolism (pe) triage, ctpa. 4.vessel occlusion (vo) triage, head cta (vo on m1). 5.intra-abdominal free gas (ifg) triage, abdomen ct. 6.incidental pulmonary embolism (ipe) triage, chest ct. 7.rib fracture (ribfx) triage, chest ct (with or without contrast). 8.brain aneurism (ba) triage, head cta. 9.pulmonary nodules (pn) qc, chest and abdomen ct (with and without contrast). 10.pneumothorax (ptx) triage, frontal chest x-ray. 11. vertically malpositioned endotracheal tube in relation to the carina (ett) 12. aortic dissection (ad) 13. vertebral compression fractures (vcfx) briefcase uses an artificial intelligence algorithm to analyse images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. the user is presented with notifications for cases with suspected findings. notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. the device does not alter the original medical image and is not intended to be used as a diagnostic device. the results of briefcase are intended to be used in conjunction with other patient information and based on the user?s professional judgment, to assist with triage/prioritization of medical images. notified clinicians are responsible for viewing full images per the standard of care.

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

acra regulatory services pty ltd - 34897 - cannula, ear, single use - a disposable ear specula that is inserted into the ear canal leaving a channel for suction or irrigation or the insertion of another surgical device. this is a single-use device.

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

acra regulatory services pty ltd - 42461 - tongue depressor, examination - a hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. this is a single-use device.

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

acra regulatory services pty ltd - 47446 - assisted reproduction vitrification carrier - sperm vd is a unique sterile labware device, intended to be used for the cryopreservation of very low numbers of human spermatozoa. once individual sperm are transferred to the device?it?is loaded into a 4 ml cryovial and placed into liquid nitrogen for long term storage. this is a single use device.

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

acra regulatory services pty ltd - 32547 - telemetry system, physiological signal - an assembly of electronic devices (tyto stethoscope, tyto otoscope, tyto exam camera and tyto thermometer) that enables transmission of various clinical examinations such as auscultation sound data (heart, lungs, heart rate) ears, throats and skin image or video and body temperature, whereby a clinician at one location on an ip network can listen to the auscultation sounds, view images and videos of a patient on site or at a different location on the ip network. the devices are intended for use by professional users in a clinical environment or by lay users in a non-clinical environment.

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

acra regulatory services pty ltd - 64612 - gastro-oesophageal antireflux fundal implant placement tool - deployment tool exclusively designed for introducing the gastro-oesophageal antireflux fundal implant into the abdominal cavity and positioning the implant at a predetermined place at fundus of the stomach. it is reusable and for sterilization by the hospital.

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

acra regulatory services pty ltd - 33586 - single-patient physiologic monitoring system - the current wearable health monitoring system is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. it is intended for monitoring of patients by trained healthcare professionals. the current wearable health monitoring system is intended to provide visual and audible physiologic multi-parameter alarms. the current wearable health monitoring system is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. the current wearable health monitoring system is intended for continuous monitoring of the following parameters in adults: ? pulse rate ? oxygen saturation ? temperature ? movement the current wearable health monitoring system is intended for intermittent or spot-check monitoring of the following parameters in adults, of: ? respiration rate ? non-invasive blood pressure ? lung function & spirometry ? weight in adults

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

acra regulatory services pty ltd - 45607 - pulse oximeter, battery-powered - non-invasive battery operated pulse oximeter intended to be used in measuring the pulse oxygen saturation of arterial haemoglobin(spo2) and pulse rate through finger in home use environments. this device is not intended for continuous monitoring. the device can be used multiple times.

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

acra regulatory services pty ltd - ct910 - interpretive software ivds - interpretative software intended to be used in antenatal screening for down?s syndrome, trisomy 18, trisomy 13, pre-eclampsia and open neural tube defects. suitable for first trimester, second trimester, integrated and reflex dna screening.

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

acra regulatory services pty ltd - 65013 - perineal orifice incontinence-control electrical stimulator, home-use - a battery powered electrical stimulator intended to be used to stimulate the muscles and nerve fibres in the pelvic area and is indicated for use: pelvic pain, back pain, stress incontinence, overactive bladder and faecal incontinence