FDA 510(k)

Hi-D Imaging 4TAVR

K-Number: K261535 · 2026-07-20

Decision Date2026-07-20

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Hi-D Imaging 4TAVR is the device name listed in this FDA 510(k) record. The listed applicant is Hi-D Imaging AG. It received FDA 510(k) clearance on 2026-07-20 under 510(k) number K261535. 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 2026-07-20. The listed applicant is Hi-D Imaging AG. The 510(k) number is K261535.

When did Hi-D Imaging 4TAVR receive FDA 510(k) clearance?

Hi-D Imaging 4TAVR received FDA 510(k) clearance on 2026-07-20, under 510(k) number K261535.

Who is the listed applicant for Hi-D Imaging 4TAVR?

The FDA 510(k) record lists Hi-D Imaging AG as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Hi-D Imaging AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241984Hi-D Imaging 4TAVR

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Official Source

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