3 devices · 2 companies · 2024 to 2026
FUJIFILM Healthcare Americas Corporation: AI-enabled devices on FDA's list
3 devices from FUJIFILM Healthcare Americas Corporation, 2024 to 2026, 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 (3 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from FUJIFILM Healthcare Americas Corporation
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Synapse PACSK261713 · 510(k) | Radiology | QIH | database entry | |
| Synapse PACSK243647 · 510(k) | Radiology | QIH | database entry | |
| ECHELON Synergy V10.0K233687 · 510(k) | Radiology | LNH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.