Hi-D Imaging 4TAVR— 510(k) K261535

Substantially Equivalent

Hi-D Imaging AG

FDA 510(k) clearance K261535 for Hi-D Imaging 4TAVR, Substantially Equivalent on 2026-07-20. Applicant: Hi-D Imaging AG. Device class: 2.

Clearance details

Applicant: Hi-D Imaging AG
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-05-08
Decision date: 2026-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Winterthur, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260192 — DIANA2026-07-24
K261349 — SwiftMR2026-07-24
K254096 — VELMENI for DENTISTS (V4D) 3D2026-07-23
K260206 — SkeletonPlanner2026-07-15
K260973 — InferOperate Suite2026-07-07

More clearances from Hi-D Imaging AG

K241984 — Hi-D Imaging 4TAVR2025-04-02

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