LUMA CERVICAL IMAGING SYSTEM is an AI-enabled medical device from SPECTRA SCIENCE, listed by FDA (PMA, P040028) with a decision date of 2006-03-16. Review panel: Obstetrics and Gynecology.
| FDA submission number | P040028 |
|---|---|
| Pathway | PMA |
| Company | SPECTRA SCIENCE |
| Review panel (specialty) | Obstetrics and Gynecology |
| FDA decision date | 2006-03-16 |
| Product code | MWM |
| Classification | Sensor, Electro-Optical (For Cervical Cancer) |
| Device class | 3 |
| Review time (calendar days) | 636 |
Official FDA database record · FDA AI-enabled device list
All Obstetrics and Gynecology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.