Cleared Traditional

K243391 - AISight Dx (FDA 510(k) Clearance)

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

K243391 · PathAI, Inc. · Pathology device
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Jun 2025
Decision
238d
Days
Class 2
Risk

K243391 is an FDA 510(k) clearance for the AISight Dx. Classified as Digital Pathology Image Viewing And Management Software (product code QKQ), Class II - Special Controls.

Submitted by PathAI, Inc. (Boston, US). The FDA issued a Cleared decision on June 26, 2025 after a review of 238 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 PathAI, Inc. devices

Submission Details

510(k) Number K243391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2024
Decision Date June 26, 2025
Days to Decision 238 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 77d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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
Devices cleared under the same product code (QKQ) and FDA review panel - the closest regulatory comparables to K243391.
INFINITT DPS
K243449 · Infinitt Healthcare Co., Ltd. · Dec 2025
HALO AP Dx
K252762 · Indica Labs, LLC · Nov 2025
PathPresenter Clinical Viewer
K250968 · Pathpresenter Corporation · Jun 2025
CaloPix
K250414 · Tribun Health · May 2025
Viewer+
K242244 · Lumea, Inc. · Mar 2025
FullFocus
K241273 · Paige.Ai, Inc. · Jan 2025