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.

Clearance details

Applicant
Hi-D Imaging AG
Product code
Code QIH
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Winterthur, CH
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