3 devices · 2 companies · 2023 to 2024
Imbio, Inc.: AI-enabled devices on FDA's list
3 devices from Imbio, Inc., 2023 to 2024, 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 (2 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Imbio, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| IQ-UIPK242467 · 510(k) | Radiology | QWO | database entry | |
| Imbio PHAK241847 · 510(k) | Radiology | QIH | database entry | |
| CAC SoftwareK230112 · 510(k) | Radiology | JAK | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.