Last updated: June 14, 2026
Back to directoryFDA-cleared automated microscopy device that digitizes peripheral blood smears and uses AI software to support blood cell pre-classification for trained review.
Labs that want a compact AI microscopy workflow for peripheral blood smear review with clear FDA source trails and technologist verification.
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
| Status | FDA 510(k) K221309 clearance source is available for AI100 with Shonit; verify current labeling and local authorization before use. |
|---|---|
| Review route | FDA 510(k) and local IVD authorization verification |
| Intended use | Automated microscopy and AI-supported review for peripheral blood smear workflows under trained professional oversight. |
| Verification note | Confirm software version, slide workflow, intended use, sample scope, trained-user requirements, and local registrations. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf22 |
Product-specific review. These product-specific signals summarize what the cited sources imply before treating SigTuple AI100 with Shonit as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Confirm FDA K221309, local registration, software version, specimen type, and user labeling before clinical deployment. Treat any workflow beyond cleared peripheral blood smear use as a separate validation and regulatory question. |
|---|---|
| Privacy | Review image storage, sample identifiers, LIS integration, user accounts, remote support, audit logs, retention, exports, encryption, and any cloud processing or service-access terms. |
| Evidence | Validate WBC differential and morphology pre-classification against local manual microscopy, abnormal case mix, rare findings, smear quality, technologist correction patterns, and turnaround-time targets. |
| Workflow | Best governed as technologist-reviewed AI microscopy support with documented review thresholds, hematopathologist escalation, QC monitoring, LIS reconciliation, and downtime procedures. |
SigTuple describes AI100 as an in-vitro diagnostic device that automates manual microscopy using robotics and AI to digitize biological samples. FDA K221309 describes AI100 with Shonit as a device for one peripheral blood smear slide at a time where software is intrinsic to imaging and analysis, so labs should match deployment to the cleared intended use and trained-review workflow.
Not for: Unreviewed diagnostic release, unsupported sample types, replacing hematology expertise, or assuming authorization outside the cleared peripheral blood smear workflow.
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
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