K260190
- 510(k) number
- K260190
- Device name
- ARTHUR
- Applicant
- ROPCA ApS DK
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2026-06-18
- Date received
- 2026-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K260190.pdf
Official FDA record: K260190
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.