LUMA CERVICAL IMAGING SYSTEM is an AI-enabled medical device from SPECTRA SCIENCE that the U.S. FDA approved through PMA P040028 on March 16, 2006. Its lead review panel is Obstetrics and Gynecology and its primary product code is MWM.
Key facts
| Submission number | P040028 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | SPECTRA SCIENCE |
| Lead review panel | Obstetrics and Gynecology |
| Primary product code | MWM |
Source: FDA AI-Enabled Medical Devices list. No matching openFDA record was found for this submission yet.
What this means
Premarket Approval (PMA) is FDA's most stringent pathway, used for Class III devices. It requires valid scientific evidence of safety and effectiveness. LUMA CERVICAL IMAGING SYSTEM went through this pathway (P040028).
Product code MWM covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. SPECTRA SCIENCE has 1 AI-enabled device on the list, and the Obstetrics and Gynecology panel accounts for 5 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.