Laboratory and hematology diagnostics
PixCell HemoScreen
Portable point-of-care hematology analyzer that uses AI-assisted VEF technology to produce CBC and 5-part differential results from small blood samples.
Last updated: June 14, 2026
Back to directorySight OLO medical AI product profile
Computer-vision hematology analyzer that provides CBC parameters and a 5-part differential from small whole-blood samples for clinical-lab use.
Laboratory and hematology diagnostics
Best fit
Sites that need compact CBC testing with visual analysis, 5-part differential results, and a reviewed point-of-care or near-patient laboratory workflow.
- Primary use case
- Computer-vision-based complete blood count analyzer with 5-part leukocyte differential from venous or capillary whole blood
- Audience
- Clinical laboratories, point-of-care testing programs, urgent care groups, pediatric sites, outpatient clinics, and health systems evaluating compact CBC testing
- Risk level
- High
- Pricing signal
- Analyzer, cartridge, quality-control, service, and distributor pricing is not public; verify current commercial availability and regional support.
- Official sources
- 4 official sources
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
Regulatory snapshot
| Status | FDA 510(k) cleared hematology analyzer records exist for Sight OLO; verify current commercialization and labeling. |
|---|---|
| Review route | 510(k) |
| Intended use | Quantitative multi-parameter automated hematology analyzer for CBC parameters and 5-part leukocyte differential from venous or capillary whole blood and fingertip samples. |
| Verification note | Check K190898 and K211840 summaries, CLIA complexity, patient age, specimen type, cartridge workflow, and current distribution before purchase. |
| 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 Sight OLO as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as a regulated in vitro diagnostic hematology analyzer. Verify K190898, K211840, current labeling, CLIA complexity, sample type, age range, and local market status before use. |
|---|---|
| Privacy | Review sample identifiers, barcode handling, instrument connectivity, result transmission, quality-control records, support access, retention, and any cloud or distributor data flow. |
| Evidence | Validate CBC and differential results against local reference analyzers across capillary, venous, pediatric, abnormal, and flagged samples before clinical reliance. |
| Workflow | Best governed through point-of-care or laboratory oversight, operator training, QC procedures, abnormal-result escalation, LIS reconciliation, and medical director review. |
Where Sight OLO fits
FDA 510(k) summaries describe Sight OLO as a compact computer-vision blood-analysis platform that screens whole blood and reports CBC parameters with a 5-part differential for children three months and older, adolescents, and adults. Sight's current site emphasizes immune-signature AI rather than a detailed OLO product page, so buyers should verify current commercialization and support status directly.
Not for: Use outside current market availability, unsupported patient ages or sample types, unsupervised diagnosis, or waived-testing assumptions not supported by the device label.
What to verify before using Sight OLO
- Current commercial availability, distributor support, FDA status, CLIA complexity, age range, sample types, and quality-control requirements.
- How the analyzer, disposable cartridges, staining, barcode or sample ID workflow, result flags, LIS connectivity, and abnormal results are reviewed.
- Local validation against reference hematology analyzers for capillary and venous samples, pediatrics, abnormal flags, turnaround time, and operator training.
- Maintenance, calibration, quality-control, cartridge supply, downtime, result correction, and post-market field-action procedures.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.sightdx.com
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / scripts / cdrh
- pmc.ncbi.nlm.nih.gov / articles / PMC9290600
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