Device Dossier

Interpretive software IVDs

Device Dossier for Interpretive software IVDs (CT910 - Interpretive software IVDs, Class 3, sponsor ACRA Regulatory Services). ARTG record, intended…

Intended purpose

Digital Imaging Software to aid in image analysis of samples mounted on microscope slides. Available applications include ASI HiBand. HiFISH, CytoPower, HiPath Pro, PathFushion and applications using the GenASIs Software Engine.

TGA Public Summary