iCAS-LV

K231690

HighRAD Ltd. · cleared 2024-03-01 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“It is a PC-based, self-contained, noninvasive image analysis software application.”

AlgorithmLesion segmentation using 3D U-Net models.

source quote (p.5)

“Lesion segmentation using 3D U-Net models.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: sphere volume; sphere volume difference; volume (cc) estimation; Sphere diameter (mm); RECIST (mm) assessments

standards: General Principles of Software Validation, Guidance for Industry and FDA Staff

Retrospective clinical

n=108 patients · 3 site(s)

endpoints: lesion volume and length (diameter); changes in lesion volume and length over time; DICE; ASSD; SHD; volume; RECIST measurements

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).