Pathology
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
Scopio Labs, Ltd.
FDA
FDA-cleared AI medical device
Digital cell-morphology software on the X100 and X100HT imaging platforms that detects, displays and classifies blood cells from a full-field peripheral blood smear to assist hematology laboratory professionals with white-blood-cell differentials, red-blood-cell morphology evaluation and platelet estimates.
FDA Submission Metadata
- Submission number
- K243144
- Decision date
- June 2025
- FDA panel
- Hematology
- Product code
- JOY
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA