Radiology AI Directory

FDA-cleared profile

Saige-Dx

DeepHealth, Inc.

Concurrent-reading software for screening DBT mammography that highlights suspected soft-tissue lesions and calcifications for physician review.

Breast imaging
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

Concurrent-reading software for screening DBT mammography that highlights suspected soft-tissue lesions and calcifications for physician review.

Overview status: Source-reviewed overview

Clinical takeaway

Saige-Dx is a concurrent-reading aid for screening DBT mammography. Its marks and suspicion information support, but do not replace, physician interpretation.

Evidence takeaway

The FDA submission describes separate reader and standalone studies. In the 240-case reader study, aided reader AUC was 0.925 versus 0.865 unaided; this reader-aided result is not a standalone sensitivity or specificity measure.

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 interpreting physicians on screening mammograms with compatible DBT hardware; it analyzes DBT stacks and accompanying full-field digital or synthetic 2D images to identify soft-tissue lesions and calcifications that may indicate cancer and assigns finding- and case-level suspicion levels.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Interpreting physicians qualified to read screening mammography examinations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Screening mammography for women aged 35 years or older using compatible DBT hardware.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Concurrent adjunctive reading aid; it does not replace physician review or clinical judgment, and decisions must not be made solely from its analysis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM x-ray mammogram files from a single DBT study, including DBT image stacks and accompanying full-field digital mammography and/or synthetic 2D images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Finding-level bounding boxes and Finding Suspicion Levels, an aggregate Case Suspicion Level, a DICOM Structured Report with markings for workstation overlay, and a DICOM Secondary Capture summary report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The FDA labels Saige-Dx as an adjunct and not a replacement for full physician review; the patient population is women aged 35 or older undergoing screening. Reader-study and standalone results are separate, and the packet does not establish current commercial version or local compatibility.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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.

FDA submission
K220105
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Breast; screening DBT findings and calcifications
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-05-12
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
DICOM Structured Report and Secondary Capture outputs are intended for overlay and review on a viewing workstation with compatible DBT hardware; the packet does not establish specific PACS, RIS, EHR, or interface versions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Result destination

workstation is explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Saige-Dx; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
Source

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 balanced MRMC reader study included 18 MQSA-qualified radiologists reading 240 cases twice, with 100 pathology-proven cancers and 140 confirmed non-cancers, using two expert truthers and adjudication when needed. Reader AUC was 0.865 unaided versus 0.925 aided (difference 0.06, 95% CI 0.041-0.079, p<0.00001); average reader sensitivity increased by 8.8% (95% CI 7.0%-10.6%) and specificity by 0.9% (95% CI -0.9% to 2.7%). A separate standalone study used 1,304 cases from nine U.S. sites and reported AUC 0.930 (95% CI 0.902-0.958). Reader deltas and AUC are not standalone sensitivity or specificity.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Value withdrawn pending re-verification
  • Corrected record
  • Exact FDA submission
  • Checked 2026-09-12

Previous value withdrawn: The old value is a change in reader sensitivity, not standalone sensitivity.

Reported specificity
Value withdrawn pending re-verification
  • Corrected record
  • Exact FDA submission
  • Checked 2026-09-12

Previous value withdrawn: The old value is the upper confidence bound for the reader-sensitivity change, not standalone specificity.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Saige-DX regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K220105
  • Samplen=1304
  • Sites9
  • IndependenceIndependence not established

K220105

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K220105 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

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 K220105. 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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-09Last searched
25Fields reviewed
9Source classes checked
1Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 1 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

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

  1. FDA K220105: Saige-Dx

    U.S. Food and Drug Administration - Published 2022-05-12 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Saige-DX model card (K220105)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K220105

    U.S. Food and Drug Administration - Accessed 2026-09-09

    Scope: postmarketSafety

Research history

  1. K220105 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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