Source document or public record
FDA 510(k) K232416 — AUTION EYE AI-4510 Urine Particle Analysis System
FDA 510(k) index record K232416. Device: AUTION EYE AI-4510 Urine Particle Analysis System. Applicant as listed: Arkray, Inc.. Decision date: 2024-05-03.
Source
"device_name": "AUTION EYE AI-4510 Urine Particle Analysis System"
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 K232416.
Device name: AUTION EYE AI-4510 Urine Particle Analysis System. Applicant as listed: Arkray, Inc..
Decision date: 2024-05-03. Decision wording: Substantially Equivalent.
Product code: LKM. Regulation: 21 CFR 864.5200. Medical specialty: Hematology.
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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