Source document or public record
FDA 510(k) K241717 — E1000 Dx Digital Pathology Solution
FDA 510(k) index record K241717. Device: E1000 Dx Digital Pathology Solution. Applicant as listed: Shandon Diagnostics Limited. Decision date: 2025-02-28.
Source
"device_name": "E1000 Dx Digital Pathology Solution"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K241717.
Device name: E1000 Dx Digital Pathology Solution. Applicant as listed: Shandon Diagnostics Limited.
Decision date: 2025-02-28. Decision wording: Substantially Equivalent.
Product code: PSY. Regulation: 21 CFR 864.3700. Medical specialty: Pathology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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