Last updated: June 14, 2026
Back to directoryDigital cell morphology system that uses robotics and AI to digitize blood and urine samples and support remote review of pre-classified reports.
Labs that want a combined blood and urine digital morphology workflow with AI-aided review, remote access, and professional approval of pre-classified results.
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
| Status | Official HORIBA materials describe Yumizen D20 as an in-vitro diagnostic device; verify current FDA, CE/IVDR, and local authorization for the exact blood and urine workflow. |
|---|---|
| Review route | Verify local IVD registration and cleared or registered intended use |
| Intended use | Digital morphology support for digitizing blood and urine samples, producing pre-classified reports, and enabling professional remote review. |
| Verification note | Confirm module configuration, cloud storage, specimen scope, remote-review claims, LIS integration, and market authorization before clinical use. |
| Source | www.horiba.com / usa / medical |
Product-specific review. These product-specific signals summarize what the cited sources imply before treating HORIBA Yumizen D20 as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as a high-risk IVD laboratory morphology workflow. Confirm the exact local authorization, specimen claims, software version, cloud features, and whether blood and urine workflows are covered in the intended market. |
|---|---|
| Privacy | Review cloud storage, remote access, sample identifiers, image retention, LIS connections, user roles, audit logs, support access, exports, and data-transfer terms before enabling networked review. |
| Evidence | Validate pre-classified blood and urine reports against local reference microscopy, abnormal case mix, sample quality, operator correction rates, turnaround time, and quality-control acceptance criteria. |
| Workflow | Best governed with laboratory director oversight, trained technologist approval, specimen-specific review rules, LIS reconciliation, QC monitoring, downtime planning, and periodic competency review. |
HORIBA describes Yumizen D20 as an in-vitro diagnostic device that uses robotics and AI to digitize blood and urine samples for AI-aided remote review and pre-classified reports. HORIBA regional materials also describe blood and urine digital morphology use, so buyers should verify exact module scope, regulatory status, cloud configuration, and local validation requirements before clinical deployment.
Not for: Autonomous diagnosis, unsupported clinical claims, unreviewed result release, use outside local IVD authorization, or deployment without specimen-specific validation.
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
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