Hi-D Imaging 4TAVR
K241984Hi-D Imaging AG · cleared 2025-04-02 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“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 with pre-operational planning and sizing for transcatheter aortic valve replacement (TAVR) procedures by providing:”
source quote (p.5)
“4TAVR utilizes an artificial intelligence (AI) deep learning model and computer vision methods that provide:”
Validation studies (3)
Bench
n=100 cases · 3 site(s)
endpoints: reproducibility
standards: FDA Guidance Document entitled, “Content of Premarket Submissions for Device Software Functions,” issued on June 14, 2023
Reader study (MRMC)
n=15 other
endpoints: 0% user errors and 95% of the cases passed without difficulty
Retrospective clinical
n=929 scans
endpoints: accuracy for annulus parameters; accuracy for other TAVR parameters
Reported performance (2 observations)
source quote (p.10)
“The acceptance criteria were set to be >90% accuracy for annulus parameters”
source quote (p.10)
“and >85% accuracy for other TAVR parameters between 4TAVR results and the mean of observers' ground truth measurements.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).