OsteoDetect is an AI-enabled medical device from Imagen Technologies, Inc., listed by FDA (De Novo, DEN180005) with a decision date of 2018-05-24. Review panel: Radiology.
| FDA submission number | DEN180005 |
|---|---|
| Pathway | De Novo |
| Company | Imagen Technologies, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2018-05-24 |
| Decision | Unknown |
| Product code | QBS |
| Classification | Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| Device class | 2 |
| Regulation number | 892.2090 |
| Review time (calendar days) | 108 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Imagen Technologies, Inc. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.