Transparency Registry · K261535
Hi-D Imaging 4TAVR
Hi-D Imaging AG · cleared 2026-07-20 under product code QIH (Automated Radiological Image Processing Software).
The public record
| 510(k) number | K261535 (FDA database) |
| Device name as cleared | Hi-D Imaging 4TAVR |
| Applicant | Hi-D Imaging AG (Winterthur, CH) |
| Decision | Substantially Equivalent · Special pathway |
| Decision date | 2026-07-20 |
| FDA product code | QIH — Automated Radiological Image Processing Software |
| Review panel | Radiology |
Source: openFDA 510(k) records, stored verbatim. Entry added 2026-08-29; the source link above is authoritative if any discrepancy exists.
Public disclosure beyond the clearance
| FDA clearance record | Located — linked above |
| Public model card / intended-use document | Not yet located in public sources |
| Peer-reviewed validation publication | Not yet located in public sources |
| Published subgroup / equity performance | Not yet located in public sources |
| Public monitoring or update commitments | Not yet located in public sources |
"Not yet located" is a statement about what we could find in public sources — not a statement about the product or whether such materials exist privately. Vendors: these rows update free of charge on submission of a public link — start here.
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