Laboratory and hematology diagnostics
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Last updated: June 14, 2026
Back to directoryRoche cobas m 511 medical AI product profile
Integrated hematology analyzer using Bloodhound digital morphology technology to count, image, classify, and present blood cells for laboratory review.
Laboratory and hematology diagnostics
Best fit
Labs evaluating a single integrated workflow for CBC, differential, reticulocytes, slide preparation, digital morphology, and review station workflows.
- Primary use case
- Integrated hematology analyzer combining CBC, slide making, staining, digital cell imaging, morphology analysis, and professional review workflows
- Audience
- Clinical hematology laboratories, hospital labs, laboratory directors, medical technologists, and health systems evaluating integrated CBC and digital morphology workflows
- Risk level
- High
- Pricing signal
- Analyzer, consumable, service, LIS, implementation, availability, and regional support pricing is not public; verify current Roche Diagnostics terms.
- Official sources
- 3 official sources
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
Regulatory snapshot
| Status | FDA K171655 describes the cobas m 511 integrated hematology analyzer; verify current commercial availability and local authorization. |
|---|---|
| Review route | FDA 510(k), CE/IVDR, Roche availability, and local IVD authorization verification |
| Intended use | Integrated CBC, differential, reticulocyte, slide preparation, digital morphology, and cell image review workflow. |
| Verification note | Confirm active product support, software version, specimen claims, viewing station workflow, LIS integration, and trained-user labeling. |
| Source | www.accessdata.fda.gov / cdrh_docs / reviews |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Roche cobas m 511 as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify current FDA 510(k), CE/IVDR, country availability, software version, specimen types, and intended use before procurement because older clearance does not guarantee active market availability. |
|---|---|
| Privacy | Review viewing station storage, LIS interfaces, image retention, user access, service connectivity, audit logs, backups, cybersecurity, and data-export policies. |
| Evidence | Validate performance against local analyzers and manual morphology for normal, abnormal, venous, capillary, and high-risk samples, with QC and review-station workflow metrics. |
| Workflow | Best governed as an integrated hematology analyzer workflow with technologist review, manual classification for exceptions, QC acceptance rules, LIS reconciliation, reagent management, and downtime plans. |
Where Roche cobas m 511 fits
Roche describes cobas m 511 as an integrated hematology analyzer using Bloodhound technology to print, stain, image, count, analyze morphology, and classify cells. FDA K171655 describes digital morphology and proprietary imaging algorithms for CBC, WBC differential, reticulocyte enumeration, and cell characterization, so buyers should verify current availability and labeling.
Not for: Replacing qualified laboratory review, unsupported specimen or indication claims, autonomous diagnosis, or assuming current availability without Roche confirmation.
What to verify before using Roche cobas m 511
- Current market availability, service support, FDA 510(k), CE/IVDR, and local authorization for the cobas m 511 system and software version.
- Which CBC, differential, reticulocyte, morphology, viewing station, LIS, quality-control, and manual-review workflows are supported.
- How sample identifiers, cell images, viewing station data, LIS messages, user activity, service access, backups, and retention are controlled.
- Local validation for venous and capillary samples, abnormal blood, morphology categories, manual review burden, QC, reagent logistics, and downtime processes.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.roche.com / media / releases
- www.accessdata.fda.gov / cdrh_docs / reviews
- pubmed.ncbi.nlm.nih.gov / 30030894
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