Data / Medical devices / United States / Imagen Technologies, Inc.
Imagen Technologies, Inc.: FDA-registered device maker in New York, NY, United States, 5 510(k) clearances
Imagen Technologies, Inc. is registered with the FDA (registration 3014661828) in New York, NY, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014661828
- Address
- 420 Lexington Avenue Suite 300, Office 365, New York, NY, United States, 10170
- Owner or operator
- Imagen Technologies, Inc. (10057966)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 3, 2020
- Registered through
- 2026
- Brand names listed
- Aorta-CAD, Chest-CAD, ChestSuite, FX, FractureDetect, Lung-CAD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radiological Computer Assisted Detection/Diagnosis Software For Fracture | QBS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2023 | K230085 | Lung-CAD | MYN | Substantially Equivalent | Imagen Technologies, Inc. | accessdata.fda.gov |
| September 13, 2023 | K223811 | Lung-CAD | MYN | Substantially Equivalent | Imagen Technologies, Inc. | accessdata.fda.gov |
| September 20, 2022 | K213353 | Aorta-CAD | MYN | Substantially Equivalent | Imagen Technologies, Inc. | accessdata.fda.gov |
| July 20, 2021 | K210666 | Chest-CAD | MYN | Substantially Equivalent | Imagen Technologies, Inc. | accessdata.fda.gov |
| July 30, 2020 | K193417 | FractureDetect (FX) | QBS | Substantially Equivalent | Imagen Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Medical Image
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Updated October 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.