PAPNET Testing System is an AI-enabled medical device from Neuromedical Systems, Inc. that the U.S. FDA approved through PMA P940029 on November 8, 1995. Its lead review panel is Pathology and its primary product code is MNM.
Key facts
| Submission number | P940029 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | Neuromedical Systems, Inc. |
| Lead review panel | Pathology |
| Primary product code | MNM |
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. PAPNET Testing System went through this pathway (P940029).
Product code MNM covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Neuromedical Systems, Inc. has 1 AI-enabled device on the list, and the Pathology panel accounts for 10 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.