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FDA 510(k)

Hi-D Imaging 4TAVR

K-Number: K241984 · 2025-04-02

ApplicantHi-D Imaging AG
Decision Date2025-04-02
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hi-D Imaging 4TAVR is a medical device manufactured by Hi-D Imaging AG. It received FDA 510(k) clearance on 2025-04-02 under approval number K241984. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hi-D Imaging 4TAVR?

Hi-D Imaging 4TAVR is a medical device that received FDA 510(k) clearance on 2025-04-02. It is manufactured by Hi-D Imaging AG. The 510(k) number is K241984.

When was Hi-D Imaging 4TAVR approved by the FDA?

Hi-D Imaging 4TAVR received FDA 510(k) clearance on 2025-04-02, under approval number K241984.

What company makes Hi-D Imaging 4TAVR?

Hi-D Imaging 4TAVR is manufactured by Hi-D Imaging AG.

What is the FDA product code for Hi-D Imaging 4TAVR?

The FDA product code for Hi-D Imaging 4TAVR is QIH.

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Official Source

View on FDA Database →

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