FDA AI Clearance Tracker/K243567
Anesthesiology · 510(k)
Tyto Insights for Rhonchi Detection
Tyto Care , Ltd.
About this listing
Tyto Insights for Rhonchi Detection from Tyto Care , Ltd. appears on the U.S. FDA list of AI-enabled medical devices under submission K243567. It went through the 510(k) pathway, reviewed by the Anesthesiology panel, with an FDA decision dated April 7, 2025. Its primary FDA product code is PHZ.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- Tyto Insights for Rhonchi Detection
- Company
- Tyto Care , Ltd.
- Submission number
- K243567
- Pathway
- 510(k)
- Decision date
- Apr 7, 2025
- Specialty (lead panel)
- Anesthesiology
- Primary product code
- PHZ
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Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.