Imagio Breast Imaging System is an AI-enabled medical device from Seno Medical Instruments, Inc. that the U.S. FDA approved through PMA P200003 on January 11, 2021. Its lead review panel is Radiology and its primary product code is QNK.
See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.
Key facts
| Submission number | P200003 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | Seno Medical Instruments, Inc. |
| Lead review panel | Radiology |
| Primary product code | QNK |
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. Imagio Breast Imaging System went through this pathway (P200003).
Product code QNK covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Seno Medical Instruments, Inc. has 1 AI-enabled device 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.