DIANA— 510(k) K260192

Substantially Equivalent

ROPCA ApS

FDA 510(k) clearance K260192 for DIANA, Substantially Equivalent on 2026-07-24. Applicant: ROPCA ApS. Device class: 2.

Clearance details

Applicant: ROPCA ApS
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-01-22
Decision date: 2026-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Odense M, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K261349 — SwiftMR2026-07-24
K254096 — VELMENI for DENTISTS (V4D) 3D2026-07-23
K261535 — Hi-D Imaging 4TAVR2026-07-20
K260206 — SkeletonPlanner2026-07-15
K260973 — InferOperate Suite2026-07-07

More clearances from ROPCA ApS

K260190 — ARTHUR2026-06-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.