Cleared Traditional

CaloPix

K250414 · Tribun Health · Pathology
May 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K250414 is an FDA 510(k) clearance for the CaloPix, a Digital Pathology Image Viewing And Management Software (Class II — Special Controls, product code QKQ), submitted by Tribun Health (Paris, FR). The FDA issued a Cleared decision on May 14, 2025, 90 days after receiving the submission on February 13, 2025. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K250414 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2025
Decision Date May 14, 2025
Days to Decision 90 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.