ProFound AI Software V2.1

K191994

iCAD Inc. · cleared 2019-10-04 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“ProFound™ AI V2.1 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems.”

Algorithmdeep learning technology

source quote (p.5)

“The ProFound AI 2.1 algorithm uses deep learning technology to process feature computations and uses pattern recognition to identify suspicious breast lesions appearing as soft tissue densities or clusters of calcifications.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Standalone

n=694 cases

endpoints: Sensitivity; Specificity; FP rates

Standalone

n=322 cases

endpoints: Sensitivity; Specificity; FP rates

Standalone

sample size not stated

endpoints: Sensitivity; AUC; FPPI

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K240417 (decision 2024-11-08) from iCAD, Inc. for a matching device line ("ProFound Detection (V4.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240417
re_clearance
The FDA AI/ML device list shows a newer 510(k) K203822 (decision 2021-03-12) from iCAD Inc. for a matching device line ("ProFound AI Software V3.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K203822

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).