# P040028: Luma Cervical Imaging System

- Pathway: PMA
- Applicant: Spectra Science
- Decided: Mar 16, 2006 after 636 days
- Product code: MWM (Sensor, Electro-Optical (For Cervical Cancer))
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 15, 2007 · Not classified · Z-0988-2007: Power supply may fail and render the unit inoperable.

Source page: https://510kreport.com/device/P040028
Methodology: https://510kreport.com/methodology