Radiology AI Directory

FDA-cleared profile

Genius AI Detection

Hologic, Inc.

Authorized purpose: Genius AI Detection analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case scoring for concurrent physician interpretation.

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.

Product overview

Start with the essentials

Authorized purpose: Genius AI Detection analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case scoring for concurrent physician interpretation.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Genius AI Detection analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case scoring for concurrent physician interpretation.

Evidence takeaway

Evidence from the reviewed source record: K201019 FDA decision material describes the cleared digital breast tomosynthesis CAD software, labeled use, and submission-specific verification. It does not establish product-wide sensitivity, specificity, outcomes, or independent clinical validation for this exact configuration.

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
Genius AI Detection analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case scoring for concurrent physician interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified interpreting physicians and trained breast-imaging professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Breast-imaging workflows using compatible DBT systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Concurrent physician review with marked findings, confidence scores, and case-level scoring.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported digital breast tomosynthesis studies from compatible systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Soft-tissue and calcification marks, confidence scores, and case scores for physician confirmation or dismissal.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Use is limited to compatible DBT systems and physician confirmation or dismissal of marks and scores; full mammography interpretation remains required.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K201019
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Breast; soft-tissue densities and calcifications in digital breast tomosynthesis
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-11-18
  • 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
The FDA package describes compatible DBT systems and physician display of marks, confidence scores, and case scores.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the interface boundary described in the exact FDA package; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified interpreting physicians and trained breast-imaging professionals should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor K201019 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Use is limited to compatible DBT systems and physician confirmation or dismissal of marks and scores; full mammography interpretation remains required.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Monitoring guidance is buyer-facing implementation guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K201019 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Deployment boundary

The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.

exact submission · checked 2026-09-04

FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The FDA package describes compatible DBT systems and physician display of marks, confidence scores, and case scores.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Use is limited to compatible DBT systems and physician confirmation or dismissal of marks and scores; full mammography interpretation remains required.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor K201019 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Use is limited to compatible DBT systems and physician confirmation or dismissal of marks and scores; full mammography interpretation remains required.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. digital breast tomosynthesis CAD software limits remain submission-specific.

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
K201019 FDA decision material describes the cleared digital breast tomosynthesis CAD software, labeled use, and submission-specific verification. It does not establish product-wide sensitivity, specificity, outcomes, or independent clinical validation for this exact configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
66.8%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

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

K201019 FDA evidence package for Genius AI Detection

  • DesignFDA 510(k) or PMA decision evidence and product verification described in the exact submission.
  • PopulationBreast; soft-tissue densities and calcifications in digital breast tomosynthesis
  • Scopeexact submission
  • Tested versionGenius AI Detection configuration described in K201019
  • IndependenceSponsor or vendor study

K201019

Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging or clinical service line and verify payer, site-of-service, coding, and coverage assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This is not a product-specific reimbursement determination. Build a local total-cost and value model and verify payer, site-of-service, coding, and coverage assumptions independently.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K201019 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

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.

Human reviewedStatus
2026-09-20Last searched
27Fields reviewed
13Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, 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 510(k) decision material K201019: Genius AI Detection

    U.S. Food and Drug Administration - Published 2020-11-18 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Genius AI Detection model card (K201019)

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

  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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K201019 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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