FDA product code QPN: Software Algorithm Device To Assist Users In Digital Pathology
QPN is the FDA product code for software algorithm device to assist users in digital pathology. It is a Class II device, regulated under 21 CFR 864.3750 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under QPN, 1 in the last five years. The average 510(k) review took 267 days (median 267); 267 days on average over the last three years. 1 De Novo request was granted under it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Software Algorithm Device To Assist Users In Digital Pathology |
| Device class | Class II |
| Regulation | 21 CFR 864.3750 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
510(k) clearances per year for QPN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 267 |
Top QPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ibex Medical Analytics , Ltd. | 1 | 2025-01-24 |
Most recent QPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241232 | Ibex Medical Analytics , Ltd. | Galen Second Read | 2025-01-24 | 267 |
Recalls for QPN devices
openFDA lists no recalls for product code QPN.
Frequently asked questions
What is FDA product code QPN?
QPN is the FDA product code for software algorithm device to assist users in digital pathology. It is a Class II device, regulated under 21 CFR 864.3750 and reviewed by the Pathology panel.
What device class is QPN?
Class II, regulation 21 CFR 864.3750. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPN?
Across 1 cleared submissions the average was 267 days from receipt to decision (median 267).
Which companies have the most QPN clearances?
Ibex Medical Analytics , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QPN
- Run a recall and safety report across every QPN manufacturer
- Watch product code QPN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.