Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-cleared profile
ProFound AI Software V2.1
iCAD Inc.
Authorized purpose: Concurrent CAD for digital breast tomosynthesis interpretation.
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: Concurrent CAD for digital breast tomosynthesis interpretation.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Concurrent CAD for digital breast tomosynthesis interpretation.
- Which images or clinical context are in scope? Modality: Mammography/DBT Anatomy or clinical context: Breast Input: DBT examinations from specifically listed Hologic, GE, and Siemens compatible systems.
- Who uses it? Intended users: Interpreting physicians and radiologists.
- What does the software produce? Output: 3D-slice marks and overlays, navigation links, and relative Certainty of Finding and Case Scores.
- What is its most important limitation? Key limitation: Scores are relative 0-100 confidence values, not malignancy probabilities, use a 50% prevalence population, and support secondary concurrent reading.
Clinical takeaway
Clinical role: Concurrent CAD for digital breast tomosynthesis interpretation.
Evidence takeaway
Evidence from the reviewed source record: Siemens Standard dataset contained 694 cases and Siemens Empire dataset contained 322 cases; packet reports specification and non-inferiority results but no numeric sensitivity or specificity values.
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 CAD for digital breast tomosynthesis interpretation.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
- Intended users
- Interpreting physicians and radiologists.
FDA packet intended-user statement.
- Care setting and population
- Research pending
Confirm the intended care setting, patient population, and service line.
- Workflow role
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- DBT examinations from specifically listed Hologic, GE, and Siemens compatible systems.
Exact FDA input and compatibility scope.
- Output and human action
- 3D-slice marks and overlays, navigation links, and relative Certainty of Finding and Case Scores.
FDA packet output scope.
- Limitations
- Scores are relative 0-100 confidence values, not malignancy probabilities, use a 50% prevalence population, and support secondary concurrent reading.
Exact FDA limitation boundary.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-premise
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
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 V2.1; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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
- Siemens Standard dataset contained 694 cases and Siemens Empire dataset contained 322 cases; packet reports specification and non-inferiority results but no numeric sensitivity or specificity values.
Submission-reported study description.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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 V2.1 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 K191994
- Samplen=694
- IndependenceIndependence not established
K191994
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K191994 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K191994. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify care setting and population: Confirm the intended care setting, patient population, and service line.
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K191994 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
23Fields reviewed
10Source 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 device recall, literature index, trial registry, fda decision summary packet, 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
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FDA K191994: ProFound AI Software V2.1
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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ProFound AI Software V2.1 model card (K191994)
Scope: intendedUsers, output, limitations, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K191994
Scope: postmarketSafety
Research history
-
K191994 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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