PIMS 1.0.0

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====== Intended use and certification status ======


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

==== Intended purpose ====

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.

==== Intended Users ====

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

==== Compliance and clinical performance ====

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.

PIMS 1.0.0

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