ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Saige-Dx (3.1.0); FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08FDA-cleared profile
Saige-Dx (3.1.0)
DeepHealth, Inc.
Authorized purpose: Concurrent reading aid for qualified interpreting physicians on screening DBT mammograms to identify soft-tissue lesions and calcifications that may indicate cancer and assign finding- and case-level suspicion.
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 reading aid for qualified interpreting physicians on screening DBT mammograms to identify soft-tissue lesions and calcifications that may indicate cancer and assign finding- and case-level suspicion.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Concurrent reading aid for qualified interpreting physicians on screening DBT mammograms to identify soft-tissue lesions and calcifications that may indicate cancer and assign finding- and case-level suspicion.
- Which images or clinical context are in scope? Modality: Mammography/DBT Anatomy or clinical context: Breast Input: X-ray mammogram DICOM files from one DBT study: DBT image stacks plus associated full-field digital mammography and/or synthetic 2D images.
- Who uses it? Intended users: Interpreting physicians qualified to read screening mammography exams.
- What does the software produce? Output: Finding-level bounding boxes and Finding Suspicion Levels, aggregate Case Suspicion Level, DICOM Structured Report with markings for overlay, and DICOM Secondary Capture summary report.
- What is its most important limitation? Key limitation: Adjunct only; not a replacement for a physician's own mammogram review, and decisions should not be made solely from Saige-Dx analysis. Labeled population is women 35+ undergoing screening mammography with compatible DBT hardware.
Clinical takeaway
Clinical role: Concurrent reading aid for qualified interpreting physicians on screening DBT mammograms to identify soft-tissue lesions and calcifications that may indicate cancer and assign finding- and case-level suspicion.
Evidence takeaway
Evidence from the reviewed source record: FDA K243688 packet identifies Saige-Dx v3.1.0 and states that verification and validation were completed. It references prior standalone and MRMC validation under K220105 and K241747, with independent testing on Hologic and GE exams, Hologic HD images, unilateral breasts, and implant-displaced views, but it does not provide numeric performance endpoints in this packet.
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 reading aid for qualified interpreting physicians on screening DBT mammograms to identify soft-tissue lesions and calcifications that may indicate cancer and assign finding- and case-level suspicion.
- Intended users
- Interpreting physicians qualified to read screening mammography exams.
- Care setting and population
- Healthcare-facility screening mammography; the cited testing used 12 US clinical sites and women 35 years and older.
- Workflow role
- Concurrent detection, localization, and characterization aid in the screening-mammography reading workflow.
- Required input
- X-ray mammogram DICOM files from one DBT study: DBT image stacks plus associated full-field digital mammography and/or synthetic 2D images.
- Output and human action
- Finding-level bounding boxes and Finding Suspicion Levels, aggregate Case Suspicion Level, DICOM Structured Report with markings for overlay, and DICOM Secondary Capture summary report.
- Limitations
- Adjunct only; not a replacement for a physician's own mammogram review, and decisions should not be made solely from Saige-Dx analysis. Labeled population is women 35+ undergoing screening mammography with compatible DBT hardware.
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
- Studies are routed from the healthcare facility to the software and results are returned to PACS or other worklist software; the packet explicitly references DICOM SR and DICOM SC outputs and a cloud-enabled deployment consideration.
- 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.
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
- FDA K243688 packet identifies Saige-Dx v3.1.0 and states that verification and validation were completed. It references prior standalone and MRMC validation under K220105 and K241747, with independent testing on Hologic and GE exams, Hologic HD images, unilateral breasts, and implant-displaced views, but it does not provide numeric performance endpoints in this packet.
- 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-Dx (3.1.0) regulatory performance study summary
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K243688
- IndependenceIndependence not established
K243688
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 K243688 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 K243688. 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 K243688 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
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. 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 1 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 K243688: Saige-Dx (3.1.0)
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-Dx (3.1.0) model card (K243688)
Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies
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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 K243688
Scope: postmarketSafety
Research history
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K243688 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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