CaloPix

CaloPix is a software-only device for viewing and managing digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. It is intended for in vitro diagnostic use as an aid to pathologists to review, interpret, and manage digital slide images for primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

CaloPix is a web-based image management software (IMS) that supports both Hamamatsu NanoZoomer S360MD (NDPI format) and Leica Aperio GT 450 DX (SVS format) scanners with specified displays. It includes panning, zooming, annotations, distance/area measurements, and manual counting tools. The primary technological difference from predicates is that CaloPix is web-based rather than Windows-based, and supports cloud or on-premises image storage.

FDA guidance documents cited: 'Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device (2016)' and 'Applying Human Factors and Usability Engineering to Medical Devices (2016)'. The pixel-wise comparison testing used the CIEDE2000 (ΔE00) color difference metric.

CaloPix has identical indications for use as the predicate devices and performs the same diagnostic image viewing and management functions (panning, zooming, measurement, annotation). Performance testing demonstrated pixel-wise color reproduction equivalent to predicate IRMS software (95th percentile of differences <3 ΔE00), accurate distance and area measurements matching predicate viewers, and adequate system turnaround times. The device operates on the same scanner hardware outputs (NDPI and SVS formats) and serves the same clinical purpose of aiding pathologist interpretation of FFPE tissue slides, establishing functional and technological equivalence despite architectural differences (web-based vs. Windows-based).