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
DeepHealth, Inc.
Authorized purpose: Provides an adjunctive BI-RADS 5th Edition breast-density category to aid assessment of breast tissue composition; it is not a diagnostic aid.
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: Provides an adjunctive BI-RADS 5th Edition breast-density category to aid assessment of breast tissue composition; it is not a diagnostic aid.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Provides an adjunctive BI-RADS 5th Edition breast-density category to aid assessment of breast tissue composition; it is not a diagnostic aid.
- Which images or clinical context are in scope? Modality: Mammography/DBT Anatomy or clinical context: Breast Input: A single mammogram study containing acceptable 2D DICOM FFDM and/or 2D synthetic images from compatible FFDM or DBT systems.
- Who uses it? Intended users: Physicians qualified to read mammography exams.
- What does the software produce? Output: An SR DICOM object and an SC DICOM object containing the same study-level breast-density category from A through D.
- What is its most important limitation? Key limitation: Intended for female patients age 35 or older undergoing mammography; adjunct only, not diagnostic, not a replacement for physician review, and not for decisions based solely on the output.
Clinical takeaway
Clinical role: Provides an adjunctive BI-RADS 5th Edition breast-density category to aid assessment of breast tissue composition; it is not a diagnostic aid.
Evidence takeaway
Evidence from the reviewed source record: FDA packet reports a retrospective multi-site study of 796 cases representing 6,170 images from five US breast-imaging centers; four-class density accuracy was 81.28% with 95% CI 78.42-83.84.
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
- Provides an adjunctive BI-RADS 5th Edition breast-density category to aid assessment of breast tissue composition; it is not a diagnostic aid.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
- Intended users
- Physicians qualified to read mammography exams.
Exact FDA intended-user statement.
- Care setting and population
- Research pending
Confirm the intended care setting, patient population, and service line.
- Workflow role
- Detection, localization, or diagnostic support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- A single mammogram study containing acceptable 2D DICOM FFDM and/or 2D synthetic images from compatible FFDM or DBT systems.
FDA device description input scope.
- Output and human action
- An SR DICOM object and an SC DICOM object containing the same study-level breast-density category from A through D.
FDA device description output scope.
- Limitations
- Intended for female patients age 35 or older undergoing mammography; adjunct only, not diagnostic, not a replacement for physician review, and not for decisions based solely on the output.
Exact FDA intended-user, population, and warning 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
- The exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- 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.
Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Saige-Density; 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
- FDA packet reports a retrospective multi-site study of 796 cases representing 6,170 images from five US breast-imaging centers; four-class density accuracy was 81.28% with 95% CI 78.42-83.84.
Submission-reported standalone evidence.
- 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 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 K222275
- Samplen=796
- IndependenceIndependence not established
K222275
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 K222275 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 K222275. 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 K222275 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
24Fields 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
-
FDA K222275: Saige-Density
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
-
Saige-Density model card (K222275)
Scope: intendedUsers, output, limitations, evidenceSummary, integration, 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 K222275
Scope: postmarketSafety
Research history
-
K222275 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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