Queen of Hearts (ACS AI ECG Model)— 510(k) DEN250044
UnknownPowerful Medical, Inc.
FDA 510(k) clearance DEN250044 for Queen of Hearts (ACS AI ECG Model), Unknown on 2026-09-03. Applicant: Powerful Medical, Inc..
Summary
Queen of Hearts (ACS AI ECG Model) is from Powerful Medical, filed under product code SHS. This record gives no name, device class, or regulation number for SHS, and it doesn't describe what the model analyzes beyond its name.
The record lists the submission type as Direct and the decision code as DENG. The classification panel is listed as Unknown, and the Cardiovascular review panel handled it.
Powerful Medical filed from New York, New York. The decision date came 346 calendar days after the received date (September 22, 2025 to September 3, 2026).
Clearance details
- Applicant
- Powerful Medical, Inc.
- Product code
- Product code SHS
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- New York, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.