Radiology DICOM image processing application software - ARTG 316044
Access comprehensive regulatory information for Radiology DICOM image processing application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 316044 and sponsored by ACRA Regulatory Services Pty Ltd, manufactured by Aidoc Medical Ltd in Israel. The device registration started on April 02, 2019.
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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.