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

philips electronics australia ltd - 57812 - radiology dicom image processing application software - the application is intended to provide processing, quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. the application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion images. the application supports correlative review and measures of physiologic, functional, and anatomic datasets from multidimensional radiographic images. it provides analytical tools to help the user quantify and document changes in these measures.

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

getz healthcare pty ltd - 57812 - radiology dicom image processing application software - subtlemr is an image processing software that can be used for image enhancement in mri images. it can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head mri.

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

getz healthcare pty ltd - 57812 - radiology dicom image processing application software - subtlepet is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (fdg), amyloid, 18f-dopa, 18f-choline, 18f-dcfpyl, ga-68 dotatate, and ga-68 psma radiotracer pet images (including pet/ct and pet/mri).

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

sydney neuroimaging analysis centre pty ltd - 57812 - radiology dicom image processing application software - veriscout is a parallel workflow tool indicated for use by trained clinicians in hospital or outpatient radiology centers. veriscout is intended to improve clinical workflow by prioritizing reporting worklists through the automated identification of features suggestive of intracranial hemorrhage on brain ct scans. veriscout results are not intended to be used on a stand-alone basis for clinical decision-making, nor is veriscout intended to rule out hemorrhage or otherwise preclude clinical assessment of ct cases. identification of suspected findings is not for diagnostic use beyond notification. additionally, preview images displayed to the clinician are of non-diagnostic quality and are only to be used for informational purposes.

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)

philips electronics australia ltd - 57812 - radiology dicom image processing application software - the intellispace portal processes clinical images from different modalities and enables advanced visualization of the images. when used by qualified personnel, it provides useful diagnostic information. intellispace portal can be used remotely by multiple users with compatible devices.

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

siemens healthcare pty ltd - 57812 - radiology dicom image processing application software - standalone diagnostic bioimaging software intended to measure and visualize cardiovascular structures.

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.

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

lc & partners pty ltd - 57812 - radiology dicom image processing application software - swiftmr is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of brain, spine, knee, ankle, shoulder, and hip mr images in dicom format. it can be used for noise reduction and increasing image sharpness for non-contrast enhanced mr images. swiftmr is not intended for use on mobile devices.

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

emergo asia pacific pty ltd t/a emergo australia - 57812 - radiology dicom image processing application software - medical imaging processing application intended for image processing and analysis of prostate mri. the application should be used by trained medical professionals, including but not limited to radiologists, urologists, and oncologists. patient management decisions should not be based solely on the results of this device. the software can be used in combination with a dicom viewer and segmentation tool that allows for image visualization and user interaction.