# K203364: MDPC-8127

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Apr 15, 2021 after 150 days
- Product code: PSY (Whole Slide Imaging System)
- 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192259: Philips IntelliSite Pathology Solution, Philips Electronics Nederland B.V. (2019) Summary page 4.

## Most influential descendants
- K242545: RadiForce MX317W-PA (2025), 0 descendants of its own

## Indications for use
The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. It is an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using the MDPC-8127. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

Source page: https://510kreport.com/device/K203364
Methodology: https://510kreport.com/methodology