PIMS use the PMA.core technology and User Interface to guarantee diagnostic accuracy

PMA.core 3.0 is a software platform for managing, distributing, viewing and annotating digital images of human tissue slides, scanned using any commercially available slide scanner capable of producing whole slide images in a supported file format. It is intended as an aid to the pathologist to review and interpret digital images for the purpose of primary histopathological diagnosis, including the measurement of any distances or surface areas relevant to making a diagnosis the pathologist annotated on these images.

PMA.core 3.0 is intended for professional use by pathologists.

PMA.core 3.0 complies with the provisions of EU Directive 98/79/EC on in vitro diagnostic medical devices. It has been validated for diagnostic use in histopathology of scanned slides stained with hematoxylin and eosin (HE), immunohistochemical (IHC) stainings or in situ hybridization (ISH) and meets the validation criteria of the College of American Pathologists (Evans et al, Arch Pathol Lab Med 2021) for diagnostic use of whole slide images for these applications. This document complies with the requirements of EU Directive 98/79/EC and MEDDEV 2.14/3 rev.1 on instructions for use for in vitro medical devices.