E1000 Dx Digital Pathology Solution— 510(k) K241717

Name: FDA 510(k) clearance K241717
Creator: U.S. Food and Drug Administration
Published: 2025-02-28

Substantially Equivalent

Shandon Diagnostics Limited

FDA 510(k) clearance K241717 for E1000 Dx Digital Pathology Solution, Substantially Equivalent on 2025-02-28. Applicant: Shandon Diagnostics Limited. Device class: 2.

Clearance details

Applicant: Shandon Diagnostics Limited
Product code: Code PSY
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2024-06-14
Decision date: 2025-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Runcorn, GB

Download summary PDF View on FDA.gov ↗

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