M1000 IMAGECHECKER is an AI-enabled medical device from Hologic, Inc., listed by FDA (PMA, P970058) with a decision date of 1998-06-26. Review panel: Radiology.
| FDA submission number | P970058 |
|---|---|
| Pathway | PMA |
| Company | Hologic, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 1998-06-26 |
| Product code | MYN |
| Classification | Analyzer, Medical Image |
| Device class | 2 |
| Regulation number | 892.2070 |
| Review time (calendar days) | 192 |
Official FDA database record · FDA AI-enabled device list
More devices from Hologic, 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.