# K172922: MMPC-4127F1

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Dec 21, 2017 after 87 days
- Product code: PZZ (Digital Pathology Display)
- 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: 1 generation back to DEN160056 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160056: Philips IntelliSite Pathology Solution, Philips Medical Systems Nederland B.V. (2017) Summary page 4.

## Indications for use
The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. 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/K172922
Methodology: https://510kreport.com/methodology