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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K260316
Device Name CMN Capillary Function with Oncology Virtual Expert
Applicant
Cercare Medical A/S
Inge Lehmanns Gade 10
Aarhus C,  DK DK-8000
Applicant Contact Mikkel Bo Hansen
Correspondent
JW Regulatory Consulting, LLC
406 Wacouta St.
Unit 417
Saint Paul,  MN  55101
Correspondent Contact Jennifer Willner
Date Received01/30/2026
Decision Date 06/22/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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