# K261535: Hi-D Imaging 4TAVR

- Pathway: 510(k) (Special)
- Applicant: Hi-D Imaging AG
- Decided: Jul 20, 2026 after 73 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K954678 (1996). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241984: Hi-D Imaging 4TAVR, Hi-D Imaging AG (2025) Summary page 5.

## Indications for use
Hi-D Imaging 4TAVR is a software as a medical device (SaMD) intended to support trained healthcare professionals (cardiologists, radiologists, clinical specialists) with the assessment of the cardiovascular anatomy and visualization and measurement of structures of the heart and vessels, including the aortic valve and femoral arteries, and with pre-procedural planning and sizing for transcatheter aortic valve replacement (TAVR) procedures by providing: * Automatic segmentation of the full heart and vessels; » 3D and 2D rendering of DICOM images; » Automatic centerline detection; » Automatic detection of the LVOT (left ventricular outflow tract), aortic, sinus, sinotubular junction (STJ), ascending aorta and descending aorta planes; » Automatic detection of abdominal aorta, left and right common iliac, left and right external iliac, left and right femoral artery planes; » Automatic multiplanar reconstruction (MPR) based on the centerline; * Measurement and visualization tools; » Manual measurement option for the user; » Automatic S-curve extraction; » Automatic report generation; Hi-D Imaging 4TAVR software is indicated for patients with tricuspid aortic stenosis who are eligible for TAVR operations and without any prior aortic valve implants.

Source page: https://510kreport.com/device/K261535
Methodology: https://510kreport.com/methodology