Transpara is an AI-enabled medical device from ScreenPoint Medical BV, listed by FDA (510(k), K181704) with a decision date of 2018-11-21. Review panel: Radiology.
| FDA submission number | K181704 |
|---|---|
| Pathway | 510(k) |
| Company | ScreenPoint Medical BV |
| Review panel (specialty) | Radiology |
| FDA decision date | 2018-11-21 |
| Decision | Substantially Equivalent |
| Product code | QDQ |
| Classification | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| Device class | 2 |
| Regulation number | 892.2090 |
| Review time (calendar days) | 147 |
| Applicant country | NL |
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.