2 devices · 2 companies · 2023 to 2026
Product code QXO: Cardiovascular Machine Learning-Based Notification Software
2 devices under product code QXO, 2023 to 2026, 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.
Cardiovascular Machine Learning-Based Notification Software. 21 CFR 870.2380, Class II. Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias. 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 |
|---|---|---|---|---|
| EchoNextK260332 · 510(k) | Pathwai, Inc. | Cardiovascular | database entry | |
| Viz HCMDEN230003 · De Novo | Viz.ai, Inc. | Cardiovascular | 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.