Cleared Traditional

AISight Dx

K243391 · PathAI, Inc. · Pathology
Jun 2025
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K243391 is an FDA 510(k) clearance for the AISight Dx, a Digital Pathology Image Viewing And Management Software (Class II — Special Controls, product code QKQ), submitted by PathAI, Inc. (Boston, US). The FDA issued a Cleared decision on June 26, 2025, 238 days after receiving the submission on October 31, 2024. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K243391 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2024
Decision Date June 26, 2025
Days to Decision 238 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.