FDA product code SII: Aortic Stenosis Machine Learning-Based Notification Software
SII is the FDA product code for aortic stenosis machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel. Devices under SII reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Aortic Stenosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of aortic stenosis for further referral or diagnostic follow-up.
Classification
| Field | Value |
|---|---|
| Device name | Aortic Stenosis 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) |
Recalls for SII devices
openFDA lists no recalls for product code SII.
Frequently asked questions
What is FDA product code SII?
SII is the FDA product code for aortic stenosis 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 SII?
Class II, regulation 21 CFR 870.2380. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SII
- Run a recall and safety report across every SII manufacturer
- Watch product code SII 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.