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FDA 510(k)

AUTION EYE AI-4510 Urine Particle Analysis System

K-Number: K232416 · 2024-05-03

ApplicantArkray, Inc.
Decision Date2024-05-03
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTION EYE AI-4510 Urine Particle Analysis System is a medical device manufactured by Arkray, Inc.. It received FDA 510(k) clearance on 2024-05-03 under approval number K232416. The device is classified under product code LKM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTION EYE AI-4510 Urine Particle Analysis System?

AUTION EYE AI-4510 Urine Particle Analysis System is a medical device that received FDA 510(k) clearance on 2024-05-03. It is manufactured by Arkray, Inc.. The 510(k) number is K232416.

When was AUTION EYE AI-4510 Urine Particle Analysis System approved by the FDA?

AUTION EYE AI-4510 Urine Particle Analysis System received FDA 510(k) clearance on 2024-05-03, under approval number K232416.

What company makes AUTION EYE AI-4510 Urine Particle Analysis System?

AUTION EYE AI-4510 Urine Particle Analysis System is manufactured by Arkray, Inc..

What is the FDA product code for AUTION EYE AI-4510 Urine Particle Analysis System?

The FDA product code for AUTION EYE AI-4510 Urine Particle Analysis System is LKM.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Arkray, Inc.

K160062AUTION ELEVEN Semi-Automated Urinalysis System K221175Multi-Lancet Device 2, ReliOn Premier Lancing Device K200788Assure Titanium Blood Glucose Monitoring System K193514AUTION MAX AX-4060 Urinalysis System

Related Devices (Code: LKM)

K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc. K200811cobas u 701 microscopy analyzerRoche Diagnostics K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. K252580iQ200 SeriesBeckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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