Source document or public record
FDA 510(k) K260023 — TumorSight Risk
FDA 510(k) index record K260023. Device: TumorSight Risk. Applicant as listed: SimBioSys, Inc.. Decision date: 2026-09-25.
Source
"device_name": "TumorSight Risk"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K260023.
Device name: TumorSight Risk. Applicant as listed: SimBioSys, Inc..
Decision date: 2026-09-25. Decision wording: Substantially Equivalent.
Product code: SHW. Regulation: 21 CFR 864.3755. 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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