SECOND LOOK ™ is an AI-enabled medical device from ICAD, INC., listed by FDA (PMA, P010034) with a decision date of 2002-01-31. Review panel: Radiology.
| FDA submission number | P010034 |
|---|---|
| Pathway | PMA |
| Company | ICAD, INC. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2002-01-31 |
| Product code | MYN |
| Classification | Analyzer, Medical Image |
| Device class | 2 |
| Regulation number | 892.2070 |
| Review time (calendar days) | 234 |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.