Cleared Traditional

Viewer+

K242244 · Lumea, Inc. · Pathology
Mar 2025
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K242244 is an FDA 510(k) clearance for the Viewer+, a Digital Pathology Image Viewing And Management Software (Class II — Special Controls, product code QKQ), submitted by Lumea, Inc. (Lehi, US). The FDA issued a Cleared decision on March 14, 2025, 226 days after receiving the submission on July 31, 2024. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K242244 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2024
Decision Date March 14, 2025
Days to Decision 226 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.