10 devices · 2 companies · 2020 to 2025
DiA Imaging Analysis Ltd.: AI-enabled devices on FDA's list
10 devices from DiA Imaging Analysis Ltd., 2020 to 2025, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (10 of 10 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| LVivo Software ApplicationK243862 · 510(k) | Radiology | QIH | database entry | |
| LVivo SeamlessK243331 · 510(k) | Radiology | QIH | database entry | |
| LVivo Software ApplicationK243235 · 510(k) | Radiology | QIH | database entry | |
| LVivo Software ApplicationK240553 · 510(k) | Radiology | QIH | database entry | |
| LVivo IQSK240769 · 510(k) | Radiology | QIH | database entry | |
| LVivo IQSK222970 · 510(k) | Radiology | QIH | database entry | |
| LVivo SeamlessK212466 · 510(k) | Radiology | QIH | database entry | |
| LVivo Software ApplicationK210053 · 510(k) | Radiology | QIH | database entry | |
| LVivo SeamlessK202546 · 510(k) | Radiology | QIH | database entry | |
| LVivo Software ApplicationK200232 · 510(k) | Radiology | QIH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.