Imaging Engineering, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251650 | Insight Enhanced DRF (EN-1002-01) | September 16, 2025 |
| K210469 | Insight Agile DRF | July 27, 2021 |
| K200396 | Insight Enhanced DRF Digital Imaging System | March 6, 2020 |
| K191310 | Insight Essentials DRF Digital Imaging System | June 10, 2019 |