# K250968: PathPresenter Clinical Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Pathpresenter Corporation
- Decided: Jun 20, 2025 after 81 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). 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)
- K233027: NanoZoomer S360MD Slide scanner system, Hamamatsu Photonics K.K. (2023) Summary page 5.

## Indications for use
For In Vitro Diagnostic Use The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.

Source page: https://510kreport.com/device/K250968
Methodology: https://510kreport.com/methodology