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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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