meddevicedb.com FDA Device Reference

Queen of Hearts (ACS AI ECG Model)

DEN250044 Direct
Decision Date
2026-09-03
Sponsor / Applicant
Powerful Medical, Inc.

Technical Specification

510(k) Submission ID DEN250044
Product Code SHS
Medical Specialty / Panel Unknown
Decision Date 2026-09-03
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Queen of Hearts (ACS AI ECG Model) received FDA 510(k) clearance under submission number DEN250044, sponsored by Powerful Medical, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-09-03.

Classification & Regulation

This clearance is catalogued under FDA product code SHS , within the Unknown review panel as a device.