Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Imagen Technologies with 6 AI-enabled devices and 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 3, 2023: Lung-CAD.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 3, 2023 | Lung-CADK230085 · MYN | 510(k) clearances |
| Oct 3, 2023 | Lung-CADK230085 · Radiology | AI-enabled devices |
| Sep 13, 2023 | Lung-CADK223811 · MYN | 510(k) clearances |
| Sep 13, 2023 | Lung-CADK223811 · Radiology | AI-enabled devices |
| Sep 20, 2022 | Aorta-CADK213353 · MYN | 510(k) clearances |
| Sep 20, 2022 | Aorta-CADK213353 · Radiology | AI-enabled devices |
| Jul 20, 2021 | Chest-CADK210666 · MYN | 510(k) clearances |
| Jul 20, 2021 | Chest-CADK210666 · Radiology | AI-enabled devices |
| Jul 30, 2020 | FractureDetect (FX)K193417 · QBS | 510(k) clearances |
| Jul 30, 2020 | FractureDetect (FX)K193417 · Radiology | AI-enabled devices |
| May 24, 2018 | OsteoDetectDEN180005 · QBS | 510(k) clearances |
| May 24, 2018 | OsteoDetectDEN180005 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
