EchoConfidence (USA)— 510(k) K250670

Substantially Equivalent

Mycardium AI Limited

FDA 510(k) clearance K250670 for EchoConfidence (USA), Substantially Equivalent on 2025-06-30. Applicant: Mycardium AI Limited.

Clearance details

Applicant: Mycardium AI Limited
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-03-05
Decision date: 2025-06-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Liverpool, GB

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Data sourced from openFDA. This site is unofficial and independent of the FDA.