DUNE MEDICAL DEVICES MARGINPROBE SYSTEM is an AI-enabled medical device from Dilon Medical Technologies, Ltd. that the U.S. FDA approved through PMA P110014 on December 27, 2012. Its lead review panel is General and Plastic Surgery and its primary product code is OEE.
Key facts
| Submission number | P110014 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | Dilon Medical Technologies, Ltd. |
| Lead review panel | General and Plastic Surgery |
| Primary product code | OEE |
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. DUNE MEDICAL DEVICES MARGINPROBE SYSTEM went through this pathway (P110014).
Product code OEE covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Dilon Medical Technologies, Ltd. has 1 AI-enabled device on the list, and the General and Plastic Surgery panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.