3 devices · 2 companies · 2020 to 2023
NICo-Lab B.V.: AI-enabled devices on FDA's list
3 devices from NICo-Lab B.V., 2020 to 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 (2 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from NICo-Lab B.V.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| StrokeViewer PerfusionK231570 · 510(k) | Radiology | LLZ | database entry | |
| HALOK211788 · 510(k) | Radiology | QAS | database entry | |
| HALOK200873 · 510(k) | Radiology | QAS | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.