# K241273: FullFocus

- Pathway: 510(k) (Traditional)
- Applicant: Paige.Ai, Inc.
- Decided: Jan 9, 2025 after 248 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)
- K232202: Aperio GT 450 DX, Leica Biosystems Imaging, Inc. (2024) Summary page 5.
- K213883: NanoZoomer S360MD Slide scanner system, Hamamatsu Photonics K.K. (2022) Summary page 5.

## Indications for use
For In Vitro Diagnostic Use FullFocus is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. FullFocus 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, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended to be used with the interoperable components specified in the below Table.

Source page: https://510kreport.com/device/K241273
Methodology: https://510kreport.com/methodology