Cleared Traditional

K233126 - aetherSlide (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K233126 is an FDA 510(k) clearance for the aetherSlide. Classified as Digital Pathology Image Viewing And Management Software (product code QKQ), Class II - Special Controls.

Submitted by Aetherai Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on May 30, 2024 after a review of 246 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aetherai Co., Ltd. devices

Submission Details

510(k) Number K233126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 77d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QKQ Digital Pathology Image Viewing And Management Software
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - QKQ Digital Pathology Image Viewing And Management Software

All 12
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