Company ยท US
Imagen Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 3, 2023 | K230085 | Lung-CAD Imagen Technologies, Inc. | MYN |
| Sep 13, 2023 | K223811 | Lung-CAD Imagen Technologies, Inc. | MYN |
| Sep 20, 2022 | K213353 | Aorta-CAD Imagen Technologies, Inc. | MYN |
| Jul 20, 2021 | K210666 | Chest-CAD Imagen Technologies, Inc. | MYN |
| Jul 30, 2020 | K193417 | FractureDetect (FX) Imagen Technologies, Inc. | QBS |
| May 24, 2018 | DEN180005 | OsteoDetect Imagen Technologies, Inc. | QBS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||