7 devices · 3 companies · 2016 to 2025
HeartFlow, Inc.: AI-enabled devices on FDA's list
7 devices from HeartFlow, Inc., 2016 to 2025, from 3 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 7 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 |
|---|---|---|---|---|
| HeartFlow AnalysisK250902 · 510(k) | Cardiovascular | PJA | database entry | |
| HeartFlow AnalysisK213857 · 510(k) | Cardiovascular | PJA | database entry | |
| HeartFlow AnalysisK203329 · 510(k) | Cardiovascular | PJA | database entry | |
| HeartFlow FFRct AnalysisK190925 · 510(k) | Cardiovascular | PJA | database entry | |
| FFRctK182035 · 510(k) | Cardiovascular | PJA | database entry | |
| FFRctK161772 · 510(k) | Cardiovascular | PJA | database entry | |
| FFRctK152733 · 510(k) | Cardiovascular | PJA | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.