Workflow role
Screening mammography review or breast-density analysis as an adjunct to qualified physician interpretation.
exact submission · checked 2026-09-04This is a submission-anchored intended-use summary, not a local acceptance result.
FDA-cleared profile
Transpara
ScreenPoint Medical BV
Authorized purpose: Transpara is a concurrent reading aid for screening mammograms that marks suspicious regions, lesions, and calcifications and provides malignancy scores for qualified physician review; patient management is not based solely on the device.
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: Transpara is a concurrent reading aid for screening mammograms that marks suspicious regions, lesions, and calcifications and provides malignancy scores for qualified physician review; patient management is not based solely on the device.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Transpara is a concurrent reading aid for screening mammograms that marks suspicious regions, lesions, and calcifications and provides malignancy scores for qualified physician review; patient management is not based solely on the device.
- Which images or clinical context are in scope? Modality: Mammography/DBT Anatomy or clinical context: Breast Input: Supported digital mammography or breast-tomosynthesis image data from compatible systems.
- Who uses it? Intended users: Qualified mammography technologists and interpreting physicians.
- What does the software produce? Output: Suspicious-region markings, scores, density measurements, density categories, or other release-specific breast-imaging outputs.
- What is its most important limitation? Key limitation: Compatible acquisition system, image quality, breast view, population, display, and physician-review requirements are release-specific. Transpara is a concurrent reading aid for screening mammograms that marks suspicious regions, lesions, and calcifications and provides malignancy scores for qualified physician review; patient management is not based solely on the device.
Clinical takeaway
Clinical role: Transpara is a concurrent reading aid for screening mammograms that marks suspicious regions, lesions, and calcifications and provides malignancy scores for qualified physician review; patient management is not based solely on the device.
Evidence takeaway
Evidence from the reviewed source record: The exact FDA submission K181704 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
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
- Transpara is a concurrent reading aid for screening mammograms that marks suspicious regions, lesions, and calcifications and provides malignancy scores for qualified physician review; patient management is not based solely on the device.
- Intended users
- Qualified mammography technologists and interpreting physicians.
- Care setting and population
- Breast-imaging practices using compatible digital mammography or tomosynthesis systems.
- Workflow role
- Screening mammography review or breast-density analysis as an adjunct to qualified physician interpretation.
- Required input
- Supported digital mammography or breast-tomosynthesis image data from compatible systems.
- Output and human action
- Suspicious-region markings, scores, density measurements, density categories, or other release-specific breast-imaging outputs.
- Limitations
- Compatible acquisition system, image quality, breast view, population, display, and physician-review requirements are release-specific. Transpara is a concurrent reading aid for screening mammograms that marks suspicious regions, lesions, and calcifications and provides malignancy scores for qualified physician review; patient management is not based solely on the device.
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
- Not established in reviewed sources
Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Input
Supported digital mammography or breast-tomosynthesis image data from compatible systems.
exact submission · checked 2026-09-04Exact supported inputs and protocol limits must be confirmed from the complete labeling.
Output
Suspicious-region markings, scores, density measurements, density categories, or other release-specific breast-imaging outputs.
exact submission · checked 2026-09-04Output review, editing, and downstream use remain release- and site-specific.
Vendor family context
Current vendor material is product-family context for K181704 only; exact release, enabled options, deployment, and local interoperability require confirmation.
product family · checked 2026-09-04Vendor material is not exact-release evidence unless that linkage is separately proven.
Site validation status
Exact local interfaces, deployment topology, security controls, downtime behavior, and support obligations remain unestablished.
exact submission · checked 2026-09-04Obtain organization-specific implementation evidence before procurement or clinical use.
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
- The exact FDA submission K181704 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
- Reported sensitivity
- 95%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
- Reported specificity
- Not established in reviewed sources
No exact submission and version-linked specificity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA submission-specific verification and validation evidence for K181704
- DesignRegulatory verification, validation, and labeling evidence reviewed for exact FDA submission K181704.
- PopulationThe labeled population and test materials for exact submission K181704; a general clinical study population is not established here.
- Scopeexact submission
- Tested versionTranspara (K181704)
- IndependenceSponsor or vendor study
K181704
FDA regulatory evidence is submission-specific but is not independent clinical performance evidence.
5 unlinked candidate evidence records are retained for source review and excluded from this evidence display.
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
No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.
- Reimbursement and coding
- Not applicable
CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.
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
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.
- Verify reimbursement and coding relevance: CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
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
28Fields reviewed
14Source classes checked
18Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 18 PubMed and 6 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 18 PubMed and 6 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, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, 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
-
FDA decision summary for K181704 - Transpara
Scope: regulatoryIdentity, productIdentity, indication, modality, anatomy, workflowRole, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Transpara model card (K181704)
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
Medicare Coverage Database
Scope: coverage, codingContext
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
ScreenPoint Transpara family context
Scope: productFamilyContext, workflowRole, implementationCapabilities
-
Artificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI): a clinical safety analysis of a randomised, controlled, non-inferiority, single-blinded, screening accuracy study.
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
-
Screening performance and characteristics of breast cancer detected in the Mammography Screening with Artificial Intelligence trial (MASAI): a randomised, controlled, parallel-group, non-inferiority, single-blinded, screening accuracy study.
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
-
Performance of an Artificial Intelligence Support System on Screening Mammography Cases Proceeding to Stereotactic Biopsy.
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
-
Wide-Angle Tomosynthesis and AI in Diagnostic Mammography
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
-
Artificial Intelligence in Breast Cancer Screening in Region Östergötland Linkoping
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Research history
-
K181704 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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