Laboratory and hematology diagnostics
Roche cobas m 511
Integrated hematology analyzer using Bloodhound digital morphology technology to count, image, classify, and present blood cells for laboratory review.
Last updated: June 14, 2026
Back to directoryCellaVision DM1200 and DM9600 medical AI product profile
Digital morphology systems for medium- and high-volume hematology labs that capture blood and body-fluid cell images and support professional cell classification review.
Laboratory and hematology diagnostics
Best fit
Labs standardizing blood smear and body-fluid morphology review across sites with trained technologist verification and hematopathology escalation.
- Primary use case
- Digital morphology systems for automated blood and body-fluid image capture, WBC/RBC pre-characterization, remote review, and hematology workflow standardization
- Audience
- Medium- and high-volume hematology laboratories, hospital networks, reference labs, medical technologists, hematopathologists, and laboratory directors
- Risk level
- High
- Pricing signal
- Analyzer, application, distributor, service, LIS, body-fluid, advanced RBC, training, and network pricing is not public; verify current regional terms.
- Official sources
- 5 official sources
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
Regulatory snapshot
| Status | FDA source records exist for CellaVision DM1200/DM96 Advanced RBC and body-fluid applications; verify current DM1200, DM9600, application, and country-specific labeling. |
|---|---|
| Review route | FDA 510(k), CE/IVDR, distributor labeling, and local IVD authorization verification |
| Intended use | Digital cell morphology support for blood and body-fluid image capture and professional review in hematology laboratories. |
| Verification note | Confirm system model, application module, specimen type, software version, body-fluid/RBC claims, and trained-user requirements. |
| 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 CellaVision DM1200 and DM9600 as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify the exact CellaVision system, software, application, distributor configuration, and specimen claim against FDA, CE/IVDR, and local labeling before using outputs in clinical reporting. |
|---|---|
| Privacy | Review local and network image storage, remote-review access, LIS integration, audit logs, role permissions, service access, exports, backups, and retention policies. |
| Evidence | Validate each application against local manual microscopy, body-fluid protocols, abnormal cell mix, RBC findings, specimen quality, technologist corrections, and hematopathologist review requirements. |
| Workflow | Best governed as professional digital morphology support with trained technologist verification, hematopathologist escalation, competency review, QC documentation, LIS reconciliation, and downtime planning. |
Where CellaVision DM1200 and DM9600 fits
CellaVision describes DM1200 and DM9600 systems as digital morphology hardware that automatically captures blood and body-fluid cell images for hematology workflows. CellaVision AI materials describe long-standing intelligent microscopy, and FDA records describe cleared Advanced RBC and body-fluid applications for specific CellaVision systems, with operator verification remaining central.
Not for: Autonomous diagnosis, unreviewed release of morphology findings, unsupported body-fluid claims, or assuming all applications and distributors carry the same local authorization.
What to verify before using CellaVision DM1200 and DM9600
- Which system, application, and workflow are in scope: DM1200, DM9600, Advanced RBC, body fluids, remote review, education, LIS, or distributor-bundled configuration.
- Current FDA, CE/IVDR, and local authorization for each system, software version, application, specimen type, and intended use.
- How blood and body-fluid images, sample identifiers, review comments, remote access, LIS messages, audit trails, support access, and retention are controlled.
- Local validation for WBC differentials, RBC morphology, body fluids, abnormal smears, rare cells, low-quality slides, correction rates, QC rules, and turnaround time.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.cellavision.com / products / hardware
- www.cellavision.com / products / hardware
- www.cellavision.com / about / news
- www.accessdata.fda.gov / cdrh_docs / reviews
- www.cellavision.com / investors / press-releases
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