Obstetrics_gynecology
LUMA CERVICAL IMAGING SYSTEM
SPECTRA SCIENCE
FDA
FDA-cleared AI medical device
An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells.
FDA Submission Metadata
- Submission number
- P040028
- Decision date
- March 2006
- FDA panel
- Obstetrics and Gynecology
- Product code
- MWM
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA PMA
P040028
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.