Radiology
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote, S.p.A.
FDA
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K253288
- Decision date
- April 2026
- FDA panel
- Radiology
- Product code
- IYN
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
K253288
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.