CMN Capillary Function with Virtual Expert for MRI, CT and CBCT— 510(k) K253831
Substantially EquivalentCercare Medical A/S
FDA 510(k) clearance K253831 for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT, Substantially Equivalent on 2026-05-18. Applicant: Cercare Medical A/S. Device class: 2.
Summary
Cercare Medical's CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is filed under LLZ, radiological image processing systems. The record doesn't expand "CMN".
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Cercare filed from Aarhus C, Denmark. The decision came 168 calendar days after receipt (December 1, 2025 to May 18, 2026).
Clearance details
- Applicant
- Cercare Medical A/S
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aarhus C, DK
Recent devices under product code LLZ
view allMore clearances from Cercare Medical A/S
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . 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.