7 devices · 1 company · 2020 to 2026
Therapixel: AI-enabled devices on FDA's list
7 devices from Therapixel, 2020 to 2026, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Therapixel
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| MammoScreenK260714 · 510(k) | Radiology | QDQ | database entry | |
| MammoScreen BDK243685 · 510(k) | Radiology | QIH | database entry | |
| MammoScreenK243679 · 510(k) | Radiology | QDQ | database entry | |
| MammoScreen BDK241561 · 510(k) | Radiology | QIH | database entry | |
| MammoScreenK240301 · 510(k) | Radiology | QDQ | database entry | |
| MammoScreen 2.0K211541 · 510(k) | Radiology | QDQ | database entry | |
| MammoScreenK192854 · 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.