7 devices · 2 companies · 2016 to 2026
Tyto Care , Ltd.: AI-enabled devices on FDA's list
7 devices from Tyto Care , Ltd., 2016 to 2026, from 2 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Tyto Care , Ltd.
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Tyto Insights for Wheeze DetectionK252844 · 510(k) | Anesthesiology | PHZ | database entry | |
| Tyto Insights for Eardrum Bulging DetectionDEN250014 · De Novo | Ear Nose & Throat | SHL | database entry | |
| Tyto StethoscopeK252089 · 510(k) | Cardiovascular | DQD | database entry | |
| Tyto Insights for Rhonchi DetectionK243567 · 510(k) | Anesthesiology | PHZ | database entry | |
| Tyto Insights for Crackles DetectionK240555 · 510(k) | Anesthesiology | PHZ | database entry | |
| Tyto Insights for Wheeze DetectionK232237 · 510(k) | Anesthesiology | PHZ | database entry | |
| Tyto StethoscopeK160401 · 510(k) | Cardiovascular | DQD | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.