510(k) K260332
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2026
- Date Received
- February 2, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cardiovascular Machine Learning-Based Notification Software
- Device Class
- Class II
- Regulation Number
- 870.2380
- Review Panel
- CV
- Submission Type
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.