Source document or public record
FDA 510(k) K253554 — Aperio GT 450 DX; Aperio GT 180 DX
FDA 510(k) index record K253554. Device: Aperio GT 450 DX; Aperio GT 180 DX. Applicant as listed: Leica Biosystems Imaging, Inc.. Decision date: 2026-08-07.
Source
"device_name": "Aperio GT 450 DX; Aperio GT 180 DX"
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 K253554.
Device name: Aperio GT 450 DX; Aperio GT 180 DX. Applicant as listed: Leica Biosystems Imaging, Inc..
Decision date: 2026-08-07. 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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