Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
Saige-Density (2.5.0)
DeepHealth, Inc
Authorized purpose: Adjunctive assignment of a BI-RADS 5th Edition breast-density category for interpreting-physician review of mammography.
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: Adjunctive assignment of a BI-RADS 5th Edition breast-density category for interpreting-physician review of mammography.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Adjunctive assignment of a BI-RADS 5th Edition breast-density category for interpreting-physician review of mammography.
- Which images or clinical context are in scope? Modality: Mammography/DBT Anatomy or clinical context: Breast tissue composition Input: A single x-ray mammogram study with acceptable 2D image DICOM files from FFDM and/or 2D synthetic images, used with compatible FFDM and DBT systems; labeled patients are females aged 35 or older undergoing mammography.
- Who uses it? Intended users: Interpreting physicians qualified to read mammography exams
- What does the software produce? Output: One study-level breast-density category from A through D under BI-RADS 5th Edition guidelines, delivered as a DICOM Structured Report containing the case-level category and a DICOM Secondary Capture summary report viewable on a mammography workstation.
- What is its most important limitation? Key limitation: The device is adjunctive and not a diagnostic aid or replacement for physician review; decisions must not rely solely on its analysis. Use is labeled for compatible FFDM/DBT systems and female patients aged 35 or older.
Clinical takeaway
Clinical role: Adjunctive assignment of a BI-RADS 5th Edition breast-density category for interpreting-physician review of mammography.
Evidence takeaway
Evidence from the reviewed source record: FDA packet: software unit, integration, and system verification plus retrospective validation described as performed under prior submission K222275. Validation data came from clinical sites distinct from algorithm-development sites, with no training/test overlap stated in this packet; K243705 itself discloses no sample size or numeric sensitivity, specificity, AUC, or other clinical performance 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
- Adjunctive assignment of a BI-RADS 5th Edition breast-density category for interpreting-physician review of mammography.
- Intended users
- Interpreting physicians qualified to read mammography exams
- Care setting and population
- Breast-imaging screening or diagnostic mammography workflow for female patients aged 35 or older
- Workflow role
- Adjunctive post-processing breast-density categorization and reporting support; physician review and judgment remain required
- Required input
- A single x-ray mammogram study with acceptable 2D image DICOM files from FFDM and/or 2D synthetic images, used with compatible FFDM and DBT systems; labeled patients are females aged 35 or older undergoing mammography.
- Output and human action
- One study-level breast-density category from A through D under BI-RADS 5th Edition guidelines, delivered as a DICOM Structured Report containing the case-level category and a DICOM Secondary Capture summary report viewable on a mammography workstation.
- Limitations
- The device is adjunctive and not a diagnostic aid or replacement for physician review; decisions must not rely solely on its analysis. Use is labeled for compatible FFDM/DBT systems and female patients aged 35 or older.
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
- DICOM SR and DICOM Secondary Capture outputs are viewable on a mammography workstation. The submission describes single-execution and cloud-enabled deployment options, but the exact commercial deployment topology and local PACS/RIS/EHR interface are not established in the packet.
- Deployment and data flow
- On-cloud
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 Saige-Density (2.5.0); FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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
- FDA packet: software unit, integration, and system verification plus retrospective validation described as performed under prior submission K222275. Validation data came from clinical sites distinct from algorithm-development sites, with no training/test overlap stated in this packet; K243705 itself discloses no sample size or numeric sensitivity, specificity, AUC, or other clinical performance values.
- 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.
Saige-Density (2.5.0) regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K243705
- IndependenceIndependence not established
K243705
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 K243705 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 K243705. 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 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 K243705 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
22Fields reviewed
9Source 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, 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 K243705: Saige-Density (2.5.0)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Saige-Density (2.5.0) model card (K243705)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
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openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K243705
Scope: postmarketSafety
Research history
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K243705 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
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Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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