Radiology AI Directory

FDA-cleared profile

ProFound AI Software V3.0

iCAD Inc.

Concurrent or secondary CAD assistance to interpreting physicians for detection, localization, and characterization of soft-tissue densities (masses, architectural distortions, and asymmetries) and calcifications; not a primary read.

Breast imagingDetection and CADe
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Concurrent or secondary CAD assistance to interpreting physicians for detection, localization, and characterization of soft-tissue densities (masses, architectural distortions, and asymmetries) and calcifications; not a primary read.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Interpreting physicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Breast imaging reading workflow using compatible DBT systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Concurrent or secondary CAD read that informs, but does not replace, the interpreting physician's primary diagnostic and patient-management decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
3D DBT exams from compatible systems: Hologic Selenia Dimensions or 3Dimensions, GE Senographe Essential with SenoClaire, GE Senographe Pristina, Siemens Inspiration, and Siemens Revelation, with the stated Siemens standard or Empire reconstructions where applicable.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Detected regions marked or contoured on DBT slices, with a Certainty of Finding score for each detected region and a Case Score for each study, each represented on a 0%-100% scale; scores and marks assist the physician in identifying findings for confirmation or dismissal.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The output is a concurrent or secondary read and does not replace clinical expertise or primary diagnostic and patient-management decisions. Certainty of Finding and Case Scores are based on a 50% cancer prevalence population, are not calibrated to the intended-use or pivotal-study prevalence, and represent relative suspicion rather than an absolute clinical probability of malignancy. Use is limited to the listed compatible DBT systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K203822
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Breast, including soft-tissue densities and calcifications in 3D DBT slices.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-03-12
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Verification and validation included deployment on a DICOM platform successfully tested for clinical network integration, with output displayed through the compatible DBT and softcopy-workstation workflow described in the packet. Specific local PACS, RIS, or interface compatibility is not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for ProFound AI Software V3.0; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
Verification included unit, integration, and regression testing. Hologic and GE supplemental standalone studies compared ProFound AI V3.0 with the prior version using case sensitivity, false-positive rate per 3D volume, and AUC, with non-inferiority conclusions for the described screening populations; paired comparisons reported increased specificity from V2.0 to V3.0. The packet text provides no numeric subject-device sensitivity, specificity, AUC, PPV, NPV, or reader-delta values.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

ProFound AI® Software V3.0 regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K203822
  • Samplen=694
  • IndependenceIndependence not established

K203822

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K203822 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K203822. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-09Last searched
20Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K203822: ProFound AI Software V3.0

    U.S. Food and Drug Administration - Published 2021-03-12 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. ProFound AI® Software V3.0 model card (K203822)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, output, evidenceSummary, anatomy, evidenceStudies

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K203822

    U.S. Food and Drug Administration - Accessed 2026-09-09

    Scope: postmarketSafety

Research history

  1. K203822 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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