510(k) K242062— 1CMR Pro

Substantially Equivalent

Mycardium AI Limited

Clearance details

Applicant: Mycardium AI Limited
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2024-07-15
Decision date: 2024-11-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Liverpool, GB

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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