4 devices · 2 companies · 2018 to 2024
icometrix NV: AI-enabled devices on FDA's list
4 devices from icometrix NV, 2018 to 2024, 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 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from icometrix NV
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| icobrain ariaK240712 · 510(k) | Radiology | QBS | database entry | |
| icobrain-ctpK192962 · 510(k) | Radiology | LLZ | database entry | |
| IcobrainK192130 · 510(k) | Radiology | LLZ | database entry | |
| icobrainK181939 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.