6 devices · 2 companies · 2018 to 2023
Imagen Technologies, Inc: AI-enabled devices on FDA's list
6 devices from Imagen Technologies, Inc, 2018 to 2023, 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 (6 of 6 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Imagen Technologies, Inc
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Lung-CADK230085 · 510(k) | Radiology | MYN | database entry | |
| Lung-CADK223811 · 510(k) | Radiology | MYN | database entry | |
| Aorta-CADK213353 · 510(k) | Radiology | MYN | database entry | |
| Chest-CADK210666 · 510(k) | Radiology | MYN | database entry | |
| FractureDetectK193417 · 510(k) | Radiology | QBS | database entry | |
| OsteoDetectDEN180005 · De Novo | Radiology | QBS | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.