Cleared Traditional

HALO AP Dx

K252762 · Indica Labs, LLC · Pathology
Nov 2025
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K252762 is an FDA 510(k) clearance for the HALO AP Dx, a Digital Pathology Image Viewing And Management Software (Class II — Special Controls, product code QKQ), submitted by Indica Labs, LLC (Albuquerque, US). The FDA issued a Cleared decision on November 25, 2025, 88 days after receiving the submission on August 29, 2025. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K252762 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2025
Decision Date November 25, 2025
Days to Decision 88 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.