Cleared Traditional

CMN Capillary Function with Oncology Virtual Expert (K260316) - FDA 510(k) Clearance

K260316 · Cercare Medical A/S · Radiology device
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Jun 2026
Decision
143d
Days
-
Risk

K260316 is an FDA 510(k) clearance for the CMN Capillary Function with Oncology Virtual Expert.

Submitted by Cercare Medical A/S (Aarhus C, DK). The FDA issued a Cleared decision on June 22, 2026 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K260316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2026
Decision Date June 22, 2026
Days to Decision 143 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 107d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -