Devices · Infinitt Healthcare Co., Ltd.

INFINITT DPS

Infinitt Healthcare Co., Ltd. is listed for INFINITT DPS (K243449). The FDA list gives December 9, 2025 as the date of the final decision. The lead panel is Pathology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QKQ as “Digital Pathology Image Viewing And Management Software”: Digital pathology image viewing and management software device 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 and interpret these digital images for the purposes of primary diagnosis. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243449

Official FDA database record

Date of final decision

December 9, 2025

Company on the FDA list

Infinitt Healthcare Co., Ltd.

Lead panel

Pathology

Primary product code

QKQ

openFDA device name for the code

Digital Pathology Image Viewing And Management Software

Device class

2

Regulation number

864.3700

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary