Reduced Ejection Fraction Machine Learning-Based Notification Software

QYE · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2380

Classification

FDA Product Code: QYE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.2380
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown