Hi-D Imaging 4TAVR— 510(k) K241984

Substantially Equivalent

Hi-D Imaging AG

FDA 510(k) clearance K241984 for Hi-D Imaging 4TAVR, Substantially Equivalent on 2025-04-02. 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: 2024-07-08
Decision date: 2025-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winterthur, CH

Download summary PDF View on FDA.gov ↗

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