Imagen Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K230085 | Lung-CAD | October 3, 2023 |
| K223811 | Lung-CAD | September 13, 2023 |
| K213353 | Aorta-CAD | September 20, 2022 |
| K210666 | Chest-CAD | July 20, 2021 |
| K193417 | FractureDetect (FX) | July 30, 2020 |
| DEN180005 | OsteoDetect | May 24, 2018 |