Laboratory_medicine
AUTION EYE AI-4510 Urine Particle Analysis System
Arkray Inc.
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K232416
- Decision date
- May 2024
- FDA panel
- Hematology
- Product code
- LKM
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Images
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.
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.