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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K260190
Device Name ARTHUR
Applicant
ROPCA ApS
Cortex Park 26 E
Odense M,  DK 5230
Applicant Contact Trine Winther
Correspondent
ROPCA ApS
Cortex Park 26 E
Odense M,  DK 5230
Correspondent Contact Trine Winther
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN   QIH  
Date Received01/22/2026
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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