Galen Second Read is an AI-enabled medical device from Ibex Medical Analytics Ltd. that the U.S. FDA cleared through 510(k) K241232 on January 24, 2025. Its lead review panel is Pathology and its primary product code is QPN (Software Algorithm Device To Assist Users In Digital Pathology).
See also all FDA AI clearances in 2025.
Key facts
| Submission number | K241232 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Ibex Medical Analytics Ltd. |
| Lead review panel | Pathology |
| Primary product code | QPN — Software Algorithm Device To Assist Users In Digital Pathology |
| Applicant (openFDA) | Ibex Medical Analytics , Ltd. |
| Applicant location | Tel Aviv, IL |
| Device class | Class 2 |
| Regulation number | 21 CFR 864.3750 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Galen Second Read went through this pathway (K241232).
openFDA lists it as a Class 2 device under 21 CFR 864.3750. Class II devices are moderate risk and are subject to general and special controls.
Product code QPN covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Ibex Medical Analytics Ltd. 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.