Ultrasound
ARTHUR
ROPCA ApS
CEFDAUKCA
FDA-cleared AI medical device
Robotic accessory that holds the transducer of a cleared ultrasound machine and uses AI to capture B-mode and Doppler images of the finger and wrist joints automatically. It is for adults under investigation or monitoring for musculoskeletal disease, in a healthcare facility, and clinicians review the images; the device gives no diagnosis.
FDA Submission Metadata
- Submission number
- K260190
- Decision date
- June 2026
- FDA panel
- Radiology
- Product code
- IYO
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals