# K233119: 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Beacon Display Technology Co., Ltd.
- Decided: Dec 28, 2024 after 458 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: 3 generations back to DEN160056 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232202: Aperio GT 450 DX, Leica Biosystems Imaging, Inc. (2024). Cleared while this submission was under review Summary page 5.

## Indications for use
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are 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. They are 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 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. The displays are 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/K233119
Methodology: https://510kreport.com/methodology