Device Dossier

Radiology DICOM image processing application software

Device Dossier for Radiology DICOM image processing application software (Radiology DICOM image processing application software, Class IIb, sponsor…

Intended purpose

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.

TGA Public Summary