LOGICON CARIES DETECTOR is an AI-enabled medical device from CARESTREAM DENTAL LLC, listed by FDA (PMA, P980025) with a decision date of 1998-09-02. Review panel: Radiology.
| FDA submission number | P980025 |
|---|---|
| Pathway | PMA |
| Company | CARESTREAM DENTAL LLC |
| Review panel (specialty) | Radiology |
| FDA decision date | 1998-09-02 |
| Product code | MYN |
| Classification | Analyzer, Medical Image |
| Device class | 2 |
| Regulation number | 892.2070 |
| Review time (calendar days) | 99 |
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.