Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Image Processing, Radiological
510(k) Number K253831
Device Name CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
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
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/01/2025
Decision Date 05/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-