ARTHUR— 510(k) K260190
Substantially EquivalentROPCA ApS
FDA 510(k) clearance K260190 for ARTHUR, Substantially Equivalent on 2026-06-18. Applicant: ROPCA ApS. Device class: 2.
Summary
ARTHUR from ROPCA is filed under IYO, pulsed echo ultrasonic imaging systems. The record doesn't describe the system beyond its name and the code name.
Class II, 21 CFR 892.1560. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
ROPCA filed from Odense M, Denmark. Review took 147 calendar days (January 22 to June 18, 2026).
Clearance details
- Applicant
- ROPCA ApS
- Product code
- Product code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Odense M, DK
Recent devices under product code IYO
view allMore clearances from ROPCA ApS
view allAdverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.