Cleared Traditional

MetaLite DX Digital Pathology Software

K240303 · Jellox Biotech, Inc. · Pathology
Oct 2024
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K240303 is an FDA 510(k) clearance for the MetaLite DX Digital Pathology Software, a Digital Pathology Image Viewing And Management Software (Class II — Special Controls, product code QKQ), submitted by Jellox Biotech, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on October 28, 2024, 269 days after receiving the submission on February 2, 2024. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K240303 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2024
Decision Date October 28, 2024
Days to Decision 269 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.