8 devices · 2 companies · 2016 to 2025
Quantib BV: AI-enabled devices on FDA's list
8 devices from Quantib BV, 2016 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 (8 of 8 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Quantib BV
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Brain WMHK251527 · 510(k) | Radiology | QIH | database entry | |
| Quantib ProstateK230772 · 510(k) | Radiology | LLZ | database entry | |
| Quantib ProstateK221106 · 510(k) | Radiology | LLZ | database entry | |
| Quantib ProstateK202501 · 510(k) | Radiology | LLZ | database entry | |
| Quantib NDK182564 · 510(k) | Radiology | LLZ | database entry | |
| Quantib BrainK173939 · 510(k) | Radiology | LLZ | database entry | |
| Quantib Brain 1.2K163013 · 510(k) | Radiology | LLZ | database entry | |
| Quantib Brain 1K153351 · 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.