FDA product code · Cardiovascular

Aortic Stenosis Machine Learning-Based Notification Software

Name: FDA decisions, review times, recalls and adverse event reports for product code SII
Creator: 510(k) Report

SIIClass II21 CFR 870.2380510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of SII at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — SII by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SII? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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