# K243449: Infinitt DPS

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Healthcare Co., Ltd.
- Decided: Dec 9, 2025 after 397 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
INFINITT DPS is a software device intended for viewing and management of whole slide digital images derived from scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It serves as an aid for pathologists to review and interpret these digital images for the purpose of pathology primary diagnosis. INFINITT DPS is intended for use with Hamamatsu NanoZoomer S360MD scanner and Barco MDPC-8127 display. It is the responsibility of the pathologist to implement appropriate procedures and safeguards that assure the integrity and accuracy of image interpretation when utilizing the INFINITT DPS. The system is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

Source page: https://510kreport.com/device/K243449
Methodology: https://510kreport.com/methodology