Cleared Traditional

aetherSlide

K233126 · Aetherai Co., Ltd. · Pathology
May 2024
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K233126 is an FDA 510(k) clearance for the aetherSlide, a Digital Pathology Image Viewing And Management Software (Class II — Special Controls, product code QKQ), submitted by Aetherai Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on May 30, 2024, 246 days after receiving the submission on September 27, 2023. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K233126 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date May 30, 2024
Days to Decision 246 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.