ARTHUR— 510(k) K260190

Name: FDA 510(k) clearance K260190
Creator: U.S. Food and Drug Administration
Published: 2026-06-18

Substantially Equivalent

ROPCA ApS

FDA 510(k) clearance K260190 for ARTHUR, Substantially Equivalent on 2026-06-18. Applicant: ROPCA ApS. Device class: 2.

Clearance details

Applicant: ROPCA ApS
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2026-01-22
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Odense M, DK

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.