510(k) K253831— CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

Substantially Equivalent

Cercare Medical A/S

Clearance details

Applicant: Cercare Medical A/S
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2025-12-01
Decision date: 2026-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aarhus C, DK

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.