6 devices · 2 companies · 2023
Annalise-AI Pty Ltd: AI-enabled devices on FDA's list
6 devices from Annalise-AI Pty Ltd, 2023, from 2 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 6 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Annalise-AI Pty Ltd
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Annalise Enterprise CTB Triage TraumaK231767 · 510(k) | Radiology | QAS | database entry | |
| Annalise Enterprise CTB Triage TraumaK231384 · 510(k) | Radiology | QAS | database entry | |
| Annalise Enterprise CTB Triage-OHK231094 · 510(k) | Radiology | QAS | database entry | |
| Annalise Enterprise CTB Triage TraumaK223240 · 510(k) | Radiology | QAS | database entry | |
| Annalise Enterprise CXR Triage TraumaK222179 · 510(k) | Radiology | QFM | database entry | |
| Annalise Enterprise CXR Triage TraumaK222268 · 510(k) | Radiology | QFM | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.