7 devices · 2 companies · 2021 to 2026
Fujifilm Corporation: AI-enabled devices on FDA's list
7 devices from Fujifilm Corporation, 2021 to 2026, from 2 companies across 6 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 Fujifilm Corporation
- QIH · Automated Radiological Image Processing Software2
- OEB · Lung Computed Tomography System, Computer-Aided Detection1
- LNH · System, Nuclear Magnetic Resonance Imaging1
- JAK · System, X-Ray, Tomography, Computed1
- QNP · Gastrointesinal Lesion Software Detection System1
- LLZ · System, Image Processing, Radiological1
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Synapse Lung Nodule AIK254075 · 510(k) | Radiology | OEB | database entry | |
| Synapse 3D Base ToolsK254189 · 510(k) | Radiology | QIH | database entry | |
| ECHELON SynergyK251386 · 510(k) | Radiology | LNH | database entry | |
| Synapse 3D Base ToolsK243762 · 510(k) | Radiology | QIH | database entry | |
| SCENARIA View Phase 5.0K250370 · 510(k) | Radiology | JAK | database entry | |
| EW10-EC02 Endoscopy Support ProgramK230751 · 510(k) | Gastroenterology-Urology | QNP | database entry | |
| Synapse 3D, Synapse 3D Base Tools v6.1K203103 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.