# K250414: CaloPix

- Pathway: 510(k) (Traditional)
- Applicant: Tribun Health
- Decided: May 14, 2025 after 90 days
- Product code: QKQ (Digital Pathology Image Viewing And Management Software)
- Device class: 2
- Regulation: 21 CFR 864.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN160056 (2017). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213883: NanoZoomer S360MD Slide scanner system, Hamamatsu Photonics K.K. (2022) Summary page 6.
- K232202: Aperio GT 450 DX, Leica Biosystems Imaging, Inc. (2024) Summary page 6.

## Indications for use
For In Vitro Diagnostic Use only CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and the validity of the interpretation of images using CaloPix. CaloPix is intended to be used with the interoperable components specified in the below Table:

Source page: https://510kreport.com/device/K250414
Methodology: https://510kreport.com/methodology