FDA 510(k) clearance · back to tracker

Hi-D Imaging 4TAVR

Hi-D Imaging AG cleared K241984 on 2025-04-02, decision: substantially equivalent

K-number

K241984

Sponsor

Hi-D Imaging AG

Device

Hi-D Imaging 4TAVR

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-04-02

Product code

QIH

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.2050

Official FDA record

Open K241984on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.