CMN Capillary Function with Oncology Virtual Expert— 510(k) K260316
Substantially EquivalentCercare Medical A/S
FDA 510(k) clearance K260316 for CMN Capillary Function with Oncology Virtual Expert, Substantially Equivalent on 2026-06-22. Applicant: Cercare Medical A/S. Device class: 2.
Summary
Cercare Medical's CMN Capillary Function with Oncology Virtual Expert is filed under QIH, automated radiological image processing software. The record doesn't expand "CMN" or describe the processing it performs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Cercare filed from Aarhus C, Denmark. The decision came 143 calendar days after FDA received it (January 30 to June 22, 2026).
Clearance details
- Applicant
- Cercare Medical A/S
- Product code
- Product code QIH
- 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
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