Anesthesiology
Tyto Insights for Crackles Detection
Tyto Care Ltd.
FDA
FDA-cleared AI medical device
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
FDA Submission Metadata
- Submission number
- K240555
- Decision date
- July 2024
- FDA panel
- Anesthesiology
- Product code
- PHZ
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Signals
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
K240555
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.