# K260190: Arthur

- Pathway: 510(k) (Traditional)
- Applicant: ROPCA ApS
- Decided: Jun 18, 2026 after 147 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922470 (1992). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161354: MELODY, Remote Control System for Ultrasound Probe, Adecho Tech (2017) Summary page 5.
- K080555: Sofia Automated Tomographic Ultrasound (Atus), Ivu Imaging Corporation (2008) Summary page 5.

## Indications for use
ARTHUR by ROPCA is intended to hold an external ultrasound transducer of cleared ultrasound equipment for automatic image capturing of finger and wrist joints. ARTHUR is indicated for adult patients, that are under investigation or monitoring of musculoskeletal diseases. The system shall be used in a professional healthcare facility environment. ARTHURs mode of operation is to use B-mode (2D), Color Doppler and/or Power Doppler mode on connected ultrasound machines. The clinical application is musculoskeletal ultrasound of the hand and wrist joints.

Source page: https://510kreport.com/device/K260190
Methodology: https://510kreport.com/methodology