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FDA 510(k)

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

K-Number: K182062 · 2018-10-30

ApplicantSysmex America, Inc.
Decision Date2018-10-30
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is a medical device manufactured by Sysmex America, Inc.. It received FDA 510(k) clearance on 2018-10-30 under approval number K182062. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device?

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is a medical device that received FDA 510(k) clearance on 2018-10-30. It is manufactured by Sysmex America, Inc.. The 510(k) number is K182062.

When was Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device approved by the FDA?

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device received FDA 510(k) clearance on 2018-10-30, under approval number K182062.

What company makes Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device?

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is manufactured by Sysmex America, Inc..

What is the FDA product code for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device?

The FDA product code for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is JOY.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026)

Other Devices by Sysmex America, Inc.

K160538Sysmex XN-L Automated Hematology Analyzer K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control K172604XW-100 Automated Hematology Analyzer for CLIA Waived Use K171883Sysmex UF-5000 Fully Automated Urine Particle Analyzer K182389Sysmex XN-L Automated Hematology Analyzer K210346Sysmex XW-100 Automated Hematology Analyzer

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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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