LUMA CERVICAL IMAGING SYSTEM

PMAP040028Obstetrics and GynecologyMWM

SPECTRA SCIENCE is listed for LUMA CERVICAL IMAGING SYSTEM (P040028). The FDA list gives March 16, 2006 as the date of the final decision. The lead panel is Obstetrics and Gynecology, and the database link on the FDA list is the PMA pathway. openFDA describes product code MWM as “Sensor, Electro-Optical (For Cervical Cancer)”: An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells. openFDA records decision code APWD for this submission. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040028

Official FDA database record

Date of final decision: March 16, 2006
Company on the FDA list: SPECTRA SCIENCE
Lead panel: Obstetrics and Gynecology
Primary product code: MWM
openFDA device name for the code: Sensor, Electro-Optical (For Cervical Cancer)
Device class: 3
Regulation number: Not returned
openFDA decision description: Not returned
openFDA decision code: APWD
Statement or summary label: Statement

Product-code text from openFDA

An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells.