QXO — Cardiovascular Machine Learning-Based Notification Software Class II
FDA product code QXO covers "Cardiovascular Machine Learning-Based Notification Software", a Class II medical device regulated under 21 CFR 870.2380. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QXO
- Device Class
- Class II
- Regulation Number
- 870.2380
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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.