Product code QYE

Device name

Reduced Ejection Fraction Machine Learning-Based Notification Software

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.2380

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset