Radiology AI Directory

FDA-cleared profile

Chest-CAD

Imagen Technologies, Inc

Authorized purpose: Concurrent CADe reading aid that identifies, categorizes, and highlights suspicious regions of interest on adult chest radiographs

Cardiac imagingMSK and boneDetection and CADe
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 CADe reading aid that identifies, categorizes, and highlights suspicious regions of interest on adult chest radiographs

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Concurrent CADe reading aid that identifies, categorizes, and highlights suspicious regions of interest on adult chest radiographs

Evidence takeaway

Evidence from the reviewed source record: Standalone testing used 20,000 chest radiographs from 12 US hospitals, outpatient centers, and specialty centers: overall sensitivity 0.908 (95% CI 0.905-0.911), specificity 0.887 (0.885-0.889), and ROC AUC 0.976 (bootstrap CI 0.975-0.976). Category AUC ranged from 0.921 to 0.994. MRMC reader study used 24 readers and 238 cases from 9 US centers: reader AUC improved 0.836 to 0.894, sensitivity 0.757 to 0.856, and specificity 0.843 to 0.870 with Chest-CAD assistance

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 CADe reading aid that identifies, categorizes, and highlights suspicious regions of interest on adult chest radiographs
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Physicians
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Adult chest-radiograph interpretation workflow; FDA bench and reader studies included hospitals, outpatient centers, and specialty centers
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Concurrent reading aid for physician interpretation, with overlay toggled in the PACS viewer; not a replacement for physician interpretation
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Adult digital chest radiograph studies received from a DICOM node
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
DICOM Presentation State overlay for each image with ROI category text and bounding boxes when suspicious ROIs are detected, or No ROI(s) Detected with no boxes; overlay can be toggled in the PACS viewer
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Indicated for adults only and intended as an assistive concurrent read; suspicious categories are broad ROIs rather than a single disease diagnosis, and physician interpretation remains necessary
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K210666
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Chest/thorax, with ROI categories covering cardiac, mediastinum/hila, lungs, pleura, bones, soft tissues, hardware, and other
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-07-20
  • 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
FDA packet describes secure cloud-based processing and delivery from a DICOM node to a PACS viewer, where the presentation-state overlay can be toggled; exact current cloud configuration, interfaces, and versions are not otherwise established
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Hybrid
  • 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 2026-09-08

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 2026-09-08

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 2026-09-08

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

ACR exact-submission catalog context

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

exact submission · checked 2026-09-08
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
Standalone testing used 20,000 chest radiographs from 12 US hospitals, outpatient centers, and specialty centers: overall sensitivity 0.908 (95% CI 0.905-0.911), specificity 0.887 (0.885-0.889), and ROC AUC 0.976 (bootstrap CI 0.975-0.976). Category AUC ranged from 0.921 to 0.994. MRMC reader study used 24 readers and 238 cases from 9 US centers: reader AUC improved 0.836 to 0.894, sensitivity 0.757 to 0.856, and specificity 0.843 to 0.870 with Chest-CAD assistance
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
90.8% (95% CI: 90.5%, 91.1%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
88.7% (95% CI: 88.5%, 88.9%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

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

Chest-CAD 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 K210666
  • Samplen=20000
  • Sites12
  • IndependenceIndependence not established

K210666

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 2026-09-08

No public price or quote for the exact K210666 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K210666. 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 2026-09-08

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
2026-09-20Last searched
24Fields 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

  1. FDA K210666: Chest-CAD

    U.S. Food and Drug Administration - Published 2021-07-20 - Accessed 2026-09-08

    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. Chest-CAD model card (K210666)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, 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 K210666

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K210666 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

Alternatives

Related tools to compare

FDA-cleared K251934

qXR-Detect

Qure.Ai Technologies

qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura,...

Modality
X-ray/Radiography
Anatomy
Chest/Lung; pleura, mediastinum/hila/heart, bone, hardware and other chest-radiograph regions
Decision
2026-01-16
Cardiac imagingMSK and boneDetection and CADe
FDA-cleared K252953

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.

Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth...

Modality
X-ray/Radiography
Anatomy
Permanent teeth and jaw/maxillofacial anatomy, including enamel, dentine, pulp, root, mental foramen, inferior alveolar canal, maxillary sinus, cementoenamel junction, crestal bone, and root-canal-treated teeth
Decision
2026-05-11
MSK and boneDetection and CADe
FDA-cleared K242437

Smile Dx®

Cube Click, Inc.

Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-05-14
MSK and boneDetection and CADeQuantification and segmentation
FDA-cleared K242171

TechCare Trauma

Milvue

Aids clinicians and radiologists reviewing 2D X-ray radiographs by detecting, localizing, and characterizing fractures across the FDA-listed appendicular, hip/pelvis, clavicle,...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2025-01-17
MSK and boneDetection and CADe