2 devices · 2 companies · 2021 to 2025
Product code QPN: Software Algorithm Device To Assist Users In Digital Pathology
2 devices under product code QPN, 2021 to 2025, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Software Algorithm Device To Assist Users In Digital Pathology. 21 CFR 864.3750, Class II. A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Galen Second ReadK241232 · 510(k) | Ibex Medical Analytics Ltd. | Pathology | database entry | |
| Paige ProstateDEN200080 · De Novo | Paige.AI | Pathology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.