Laboratory_medicine
Seaman Pro/Seaman
Checkcells, Inc.
FDA
FDA-cleared AI medical device
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.
FDA Submission Metadata
- Submission number
- K252228
- Decision date
- April 2026
- FDA panel
- Hematology
- Product code
- POV
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA 510k
K252228
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.