Obstetrics and Gynecology · PMA · 2006
LUMA CERVICAL IMAGING SYSTEM
SPECTRA SCIENCE. Approved by FDA on 16 March 2006 under submission P040028, product code MWM (sensor, electro-optical (for cervical cancer)). What FDA's record says, in FDA's words.
Device record · P040028
- Device. LUMA CERVICAL IMAGING SYSTEMDEVICE
- Company. SPECTRA SCIENCECOMPANY
- Decision. 16 March 2006, PMA, apwdDECISION
- Panel. Obstetrics and GynecologyPANEL
- Product code. MWM, Sensor, Electro-Optical (For Cervical Cancer)CODE
- Source. FDA database entrySOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
The product code's definition, from FDA's classification record. An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code MWM. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MWM, in Obstetrics and Gynecology, or approved in 2006. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.