Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imagen Technologies, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
265 daysmedian FDA review time
347 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230085 | Lung-CAD | Imagen Technologies, Inc. | 2023-10-03 | 265 | 0 |
| K223811 | Lung-CAD | Imagen Technologies, Inc. | 2023-09-13 | 267 | 0 |
| K213353 | Aorta-CAD | Imagen Technologies, Inc. | 2022-09-20 | 347 | 0 |
| K210666 | Chest-CAD | Imagen Technologies, Inc. | 2021-07-20 | 137 | 0 |
| K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020-07-30 | 234 | 0 |
| DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018-05-24 | 108 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda