Laboratory and hematology diagnostics
Sight OLO
Computer-vision hematology analyzer that provides CBC parameters and a 5-part differential from small whole-blood samples for clinical-lab use.
Last updated: June 14, 2026
Back to directoryCellaVision DC-1 medical AI product profile
Digital hematology morphology analyzer for lower-volume labs that captures blood smear images and helps staff review pre-classified cells.
Laboratory and hematology diagnostics
Best fit
Smaller labs that want a digital morphology workflow without a large track-based system, while keeping trained staff responsible for verification.
- Primary use case
- Single-slide digital morphology analyzer for blood cell differential review with automated image capture and cell pre-classification
- Audience
- Small and medium-volume hematology laboratories, laboratory directors, medical technologists, hospital networks, and regional lab groups
- Risk level
- High
- Pricing signal
- Analyzer, software, reagent, distributor, service, and implementation pricing varies by region; verify current CellaVision or Sysmex terms.
- Official sources
- 4 official sources
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
Regulatory snapshot
| Status | CellaVision product materials list CE and 510(k) clearance; verify current local availability and exact software configuration. |
|---|---|
| Review route | 510(k) and CE per official product materials |
| Intended use | Digital morphology analysis support for blood cell differential workflows in low-volume laboratories. |
| Verification note | Confirm whether the deployed configuration covers the intended specimen, analyzer, reagent, LIS, and review workflow before clinical use. |
| Source | www.cellavision.com / products / hardware |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating CellaVision DC-1 as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as a regulated laboratory morphology workflow. Verify CE, 510(k), local registration, specimen claims, and distributor terms for the exact analyzer and software version. |
|---|---|
| Privacy | Review slide image storage, sample identifiers, networked installation, support access, LIS export, audit logs, retention, and user permissions across standalone and lab-network configurations. |
| Evidence | Validate pre-classification and review performance using local smear quality, abnormal case mix, low-volume staffing patterns, manual comparison, and quality-control acceptance criteria. |
| Workflow | Best governed as a technologist-reviewed digital morphology aid with laboratory director oversight, training, correction workflow, LIS release checks, and periodic competency review. |
Where CellaVision DC-1 fits
CellaVision describes DC-1 as a low-volume digital morphology analyzer that automatically captures blood smear cell images and supports WBC, RBC, platelet, and feathered-edge review. CellaVision and Sysmex materials state CE and 510(k) clearance signals for DC-1, while CellaVision's AI materials explain that intelligent microscopy and pre-classification are central to its digital morphology products.
Not for: Autonomous result release, use outside cleared or registered markets, unsupported specimen workflows, or deployment without local comparison to manual review.
What to verify before using CellaVision DC-1
- Current CE, 510(k), distributor, and market availability for the exact DC-1 configuration and geography.
- Which blood, body-fluid, smear, reagent, and software workflows are supported and how RBC, WBC, platelet, and feathered-edge review are handled.
- How images, patient identifiers, operator corrections, networked review, LIS export, support access, retention, and audit trails are managed.
- Local validation for turnaround time, missed abnormal cells, pre-classification accuracy, review burden, operator competency, and quality-control procedures.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.cellavision.com / products / hardware
- www.cellavision.com / about / news
- www.sysmex.com / en-us / lab-solutions
- www.prnewswire.com / news-releases / sysmex-america-to-distribute-fda-cleared-cellavision-dc-1-for-low-volume-hematology-labs-301174696.html
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