FDA product code QXX: Coronary Artery Disease Machine Learning-Based Notification Software
QXX is the FDA product code for coronary artery disease machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QXX, 1 in the last five years. The average 510(k) review took 7 days (median 7).
Definition
Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up.
Classification
| Field | Value |
|---|---|
| Device name | Coronary Artery Disease Machine Learning-Based Notification Software |
| Device class | Class II |
| Regulation | 21 CFR 870.2380 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QXX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 7 |
Compare with all 510(k) review times · Search every QXX clearance
Top QXX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corvista Health, Inc. | 1 | 2023-09-08 |
Most recent QXX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232686 | Corvista Health, Inc. | CorVista® System | 2023-09-08 | 7 |
Recalls for QXX devices
openFDA lists no recalls for product code QXX.
Frequently asked questions
What is FDA product code QXX?
QXX is the FDA product code for coronary artery disease machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel.
What device class is QXX?
Class II, regulation 21 CFR 870.2380. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXX?
Across 1 cleared submissions the average was 7 days from receipt to decision (median 7).
Which companies have the most QXX clearances?
Corvista Health, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QXX
- Run a recall and safety report across every QXX manufacturer
- Watch product code QXX 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.
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