Laboratory and hematology diagnostics
Sysmex DI-60
Automated digital cell morphology system that captures and pre-classifies blood cells so trained laboratory staff can review and verify differentials.
Last updated: June 14, 2026
Back to directoryScopio Full-Field Digital Cell Morphology medical AI product profile
AI-enabled full-field digital cell morphology platform for hematology labs reviewing blood smears and bone marrow aspirates with professional oversight.
Laboratory and hematology diagnostics
Best fit
Labs that need remote digital morphology, higher-throughput smear review, AI pre-classification, and collaboration across hematology or hematopathology teams.
- Primary use case
- Full-field peripheral blood smear and bone marrow aspirate digital morphology with AI-powered decision support and remote review
- Audience
- Hematology laboratories, laboratory directors, hematopathologists, technologists, health-system lab automation teams, and digital morphology programs
- Risk level
- High
- Pricing signal
- Capital equipment, distributor, service, slide-loader, application, and implementation pricing is not public; verify current Scopio, Beckman Coulter, or Siemens channel terms.
- Official sources
- 5 official sources
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
Regulatory snapshot
| Status | FDA 510(k) cleared applications are listed for Scopio X100 and X100HT peripheral blood smear workflows; verify the exact current application and geography. |
|---|---|
| Review route | 510(k) |
| Intended use | Locate and display white cells, red cells, and platelets from fixed and stained peripheral blood smears to assist qualified users with WBC differential, RBC morphology evaluation, and platelet estimate. |
| Verification note | Confirm whether bone marrow, complete blood morphology, RBC, platelet, or other added decision-support features are included in the deployed clearance and software version. |
| Source | www.accessdata.fda.gov / scripts / cdrh |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Scopio Full-Field Digital Cell Morphology as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | High-risk in vitro diagnostic lab workflow. Match K201301, K220013, later clearances, IVDR, CE, and local requirements to the exact application, software version, specimen type, and professional-user setting. |
|---|---|
| Privacy | Review digital slide images, sample IDs, remote viewer access, hospital-network setup, distributor support access, audit logs, retention, exports, and any cloud or browser-based collaboration features. |
| Evidence | Compare AI pre-classification and morphology support against local manual review, abnormal smear mix, rare-cell cases, scanner performance, false classifications, and technologist/pathologist override patterns. |
| Workflow | Best governed as technologist- and pathologist-reviewed digital morphology support with documented review, exception handling, LIS result release rules, downtime plans, and quality monitoring. |
Where Scopio Full-Field Digital Cell Morphology fits
Scopio and distributor pages describe X100 and X100HT as full-field digital morphology platforms with AI-powered decision support for peripheral blood smear workflows. FDA records list 510(k) clearances for Scopio X100 and X100HT peripheral blood smear applications, while Scopio announcements describe additional clearances and IVDR progress. Treat each claim as application-specific and verify the current label before clinical use.
Not for: Autonomous diagnosis, unreviewed result release, unsupported specimen types, or use outside the cleared application, professional-user, and local laboratory validation boundaries.
What to verify before using Scopio Full-Field Digital Cell Morphology
- Which platform and application are in scope: X100, X100HT, peripheral blood smear, bone marrow aspirate, RBC morphology, platelet estimate, or complete blood morphology.
- Current FDA, IVDR, CE, and local authorization for the exact application, software version, specimen type, and geography.
- How images, sample identifiers, remote access, user corrections, AI pre-classifications, LIS links, audit logs, and retention are handled.
- Local validation against manual microscopy, smear quality, abnormal flags, rare cells, technologist review time, pathologist escalation, and quality-control procedures.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- scopiolabs.com
- www.beckmancoulter.com / products / hematology
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / scripts / cdrh
- pmc.ncbi.nlm.nih.gov / articles / PMC9293172
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