510(k) K250649

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 19, 2025

Date Received

March 4, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Reduced Ejection Fraction Machine Learning-Based Notification Software

Device Class

Class II

Regulation Number

870.2380

Review Panel

CV

Submission Type

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.