6 devices · 2 companies · 2019 to 2024
ScreenPoint Medical B.V.: AI-enabled devices on FDA's list
6 devices from ScreenPoint Medical B.V., 2019 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 (6 of 6 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from ScreenPoint Medical B.V.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| TransparaK241831 · 510(k) | Radiology | QDQ | database entry | |
| Transpara Density 1.0.0K232096 · 510(k) | Radiology | QIH | database entry | |
| Transpara 1.7.2K221347 · 510(k) | Radiology | QDQ | database entry | |
| Transpara 1.7.0K210404 · 510(k) | Radiology | QDQ | database entry | |
| TransparaK193229 · 510(k) | Radiology | QDQ | database entry | |
| TransparaK192287 · 510(k) | Radiology | QDQ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.