Cleared Traditional

INFINITT DPS

K243449 · Infinitt Healthcare Co., Ltd. · Pathology
Dec 2025
Decision
397d
Days
Class 2
Risk

About This 510(k) Submission

K243449 is an FDA 510(k) clearance for the INFINITT DPS, a Digital Pathology Image Viewing And Management Software (Class II — Special Controls, product code QKQ), submitted by Infinitt Healthcare Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 9, 2025, 397 days after receiving the submission on November 7, 2024. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K243449 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2024
Decision Date December 09, 2025
Days to Decision 397 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code QKQ — Digital Pathology Image Viewing And Management Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.3700
Definition 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.