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, pattern recognition
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)No
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Standalone

n=694 cases

endpoints: Sensitivity; Specificity; FP rates; false positive rate per tomosynthesis image volume

Standalone

n=322 cases

endpoints: Sensitivity; Specificity; FP rates; false positive rate per tomosynthesis image volume

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
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); 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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K191994