FDA product code SIK: Cardiac Hypertrophy Machine Learning-Based Notification Software
SIK is the FDA product code for cardiac hypertrophy 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 SIK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Cardiac hypertrophy machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac hypertrophy for further referral or diagnostic follow-up.
Classification
| Field | Value |
|---|---|
| Device name | Cardiac Hypertrophy 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 SIK devices
openFDA lists no recalls for product code SIK.
Frequently asked questions
What is FDA product code SIK?
SIK is the FDA product code for cardiac hypertrophy 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 SIK?
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 SIK
- Run a recall and safety report across every SIK manufacturer
- Watch product code SIK 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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