510(k) clearance

Queen of Hearts (ACS AI ECG Model)

FDA 510(k) source

510(k) number

DEN250044

Applicant

Powerful Medical, Inc.

Decision date

Sep 3, 2026

Date received

Sep 22, 2025

Decision

Unknown

Clearance type

Direct

Product code

SHS

Advisory committee

Unknown

Third party

N

Location

New York, NY, US