PowerLook® Tomo Detection Software is an AI-enabled medical device from iCAD Inc that the U.S. FDA approved through PMA P160009 on March 24, 2017. Its lead review panel is Radiology and its primary product code is MYN.
See also FDA-cleared AI radiology devices in 2017, all FDA AI clearances in 2017, top radiology AI devices.
Key facts
| Submission number | P160009 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | iCAD Inc |
| Lead review panel | Radiology |
| Primary product code | MYN |
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. PowerLook® Tomo Detection Software went through this pathway (P160009).
Product code MYN covers 43 devices on the FDA AI list. By decision date, this device is #6 of 43 under that code. iCAD Inc has 7 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
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