3 devices · 2 companies · 2020 to 2025
Ezra AI, Inc.: AI-enabled devices on FDA's list
3 devices from Ezra AI, Inc., 2020 to 2025, 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 (3 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Ezra AI, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Ezra FlashK242334 · 510(k) | Radiology | QIH | database entry | |
| Ezra FlashK230264 · 510(k) | Radiology | LLZ | database entry | |
| Ezra Plexo SoftwareK192969 · 510(k) | Radiology | QIH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.