Hi-D Imaging 4TAVR

K241984

Hi-D Imaging AG · cleared 2025-04-02 · product code QIH · Radiology

FDA 510(k) summary for Hi-D Imaging 4TAVR (K241984)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
1
Performance observations
0
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
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:”
Algorithmartificial intelligence (AI) deep learning model and computer vision methods
source quote (p.5)
“4TAVR utilizes an artificial intelligence (AI) deep learning model and computer vision methods that provide: 1) Fast and reliable automated analysis, 2) Fully automated segmentation of CT-based cardiac anatomy data, 3) 3D reconstruction and visualization of the anatomy, and 4) Fully automated report generation.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

n=100 cases · 3 site(s)

endpoints: reproducibility of 4TAVR

Retrospective clinical

n=929 scans

endpoints: accuracy for annulus parameters; accuracy for other TAVR parameters

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
4
drift signals on this device
  • predicate_cohort_contagion

    K241984 shares predicate K153736 with K191585 (iNtuition-Structural Heart Module), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K153736 sibling:K191585

  • predicate_cohort_contagion

    K241984 shares predicate K153736 with K202212 (TruPlan), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K153736 sibling:K202212

  • predicate_cohort_contagion

    K241984 shares predicate K153736 with K222593 (TruPlan Computed Tomography (CT) Imaging Software), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K153736 sibling:K222593

  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-08-26.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K241984