QuantX is an AI-enabled medical device from Quantitative Insights, Inc, listed by FDA (De Novo, DEN170022) with a decision date of 2017-07-19. Review panel: Radiology.
| FDA submission number | DEN170022 |
|---|---|
| Pathway | De Novo |
| Company | Quantitative Insights, Inc |
| Review panel (specialty) | Radiology |
| FDA decision date | 2017-07-19 |
| Decision | Unknown |
| Product code | POK |
| Classification | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Device class | 2 |
| Regulation number | 892.2060 |
| Review time (calendar days) | 103 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.