Imagen Technologies, Inc.: FDA clearances and approvals
Imagen Technologies, Inc. has 5 FDA 510(k) clearances (first 2020, latest 2023), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 265 days. Since 2017 its median was 265 days, against 201 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 234 |
| 2021 | 1 | 137 |
| 2022 | 1 | 347 |
| 2023 | 2 | 266 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Imagen Technologies, Inc.'s cleared 510(k)s took a median 265 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 201 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MYN | Analyzer, Medical Image | 4 | 4 |
| QBS | Radiological Computer Assisted Detection/Diagnosis Software For Fracture | 2 | 1 |
Review panels
- Radiology (6)
Most recent Imagen Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230085 | Lung-CAD | MYN | 2023-10-03 | 265 |
| K223811 | Lung-CAD | MYN | 2023-09-13 | 267 |
| K213353 | Aorta-CAD | MYN | 2022-09-20 | 347 |
| K210666 | Chest-CAD | MYN | 2021-07-20 | 137 |
| K193417 | FractureDetect (FX) | QBS | 2020-07-30 | 234 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180005 | De Novo | Radiological Computer Assisted Detection/Diagnosis Software For Fracture | 2018-05-24 |
Recalls
openFDA lists no recalls under a recalling firm named Imagen Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Imagen Technologies, Inc. have?
Imagen Technologies, Inc. has 5 FDA 510(k) clearances (first 2020, latest 2023), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Imagen Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Imagen Technologies, Inc.'s cleared 510(k)s is 265 days. Since 2017: 265 days, versus 201 days for all cleared 510(k)s in the same product codes.
What devices does Imagen Technologies, Inc. make?
Its most frequent FDA product codes are MYN (Analyzer, Medical Image, 4); QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture, 2).
Has Imagen Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Imagen Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 5 Imagen Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MYN, Imagen Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.