Imagen Technologies, Inc.
New York, NY, US
IMAGEN TECHNOLOGIES, INC. appears in FDA device records in New York, NY. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Imagen Technologies, Inc. between 2018 and 2023. The busiest year on record is 2023, with 2. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230085 | Lung-CAD | MYN | Substantially Equivalent | |
| K223811 | Lung-CAD | MYN | Substantially Equivalent | |
| K213353 | Aorta-CAD | MYN | Substantially Equivalent | |
| K210666 | Chest-CAD | MYN | Substantially Equivalent | |
| K193417 | FractureDetect (FX) | QBS | Substantially Equivalent | |
| DEN180005 | OsteoDetect | QBS | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014661828 | 3014661828 | IMAGEN TECHNOLOGIES, INC. | 420 Lexington Avenue, New York, NY 10170 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain