AISight Dx— 510(k) K243391

Substantially Equivalent

PathAI, Inc.

FDA 510(k) clearance K243391 for AISight Dx, Substantially Equivalent on 2025-06-26. Applicant: PathAI, Inc.. Device class: 2.

Clearance details

Applicant: PathAI, Inc.
Product code: Code QKQ
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2024-10-31
Decision date: 2025-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.