3 devices · 2 companies · 2021 to 2025
Quibim S.L.: AI-enabled devices on FDA's list
3 devices from Quibim S.L., 2021 to 2025, 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 (3 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Quibim S.L.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| QP-Prostate CADK242683 · 510(k) | Radiology | QDQ | database entry | |
| QP-BrainK232231 · 510(k) | Radiology | QIH | database entry | |
| QUIBIM Precision ProstateK203582 · 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.