Hi-D Imaging 4TAVR— 510(k) K261535

Name: FDA 510(k) clearance K261535
Creator: U.S. Food and Drug Administration
Published: 2026-07-20

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.

Summary

Hi-D Imaging 4TAVR from Hi-D Imaging AG is filed under QIH, automated radiological image processing software. The record doesn't expand "TAVR" or describe the software's outputs.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).

Hi-D Imaging filed from Winterthur, Switzerland. The decision came 73 calendar days after receipt (May 8 to July 20, 2026).

Clearance details

Applicant: Hi-D Imaging AG
Product code: Product 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 ↗

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