Radiology AI Directory

FDA-cleared profile

Aorta-CAD

Imagen Technologies, Inc

Authorized purpose: Concurrent-read CADe to aid physicians in detecting and localizing chest-radiograph ROIs labeled aortic calcification or dilated aorta, suggestive of aortic atherosclerosis or aortic ectasia; it does not replace the physician or other standard-of-care testing.

Detection 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-read CADe to aid physicians in detecting and localizing chest-radiograph ROIs labeled aortic calcification or dilated aorta, suggestive of aortic atherosclerosis or aortic ectasia; it does not replace the physician or other standard-of-care testing.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Concurrent-read CADe to aid physicians in detecting and localizing chest-radiograph ROIs labeled aortic calcification or dilated aorta, suggestive of aortic atherosclerosis or aortic ectasia; it does not replace the physician or other standard-of-care testing.

Evidence takeaway

Evidence from the reviewed source record: FDA standalone testing assessed 5,000 chest radiograph cases representative of the intended population. Overall sensitivity was 0.910 (95% Wilson CI 0.896-0.922), specificity was 0.896 (0.889-0.902), and ROC AUC was 0.974 (95% bootstrap CI 0.971-0.977). Category results were separate: aortic-calcification sensitivity/specificity 0.922/0.894 and dilated-aorta sensitivity/specificity 0.830/0.897. A fully crossed MRMC reader study used 244 cases and found aided-versus-unaided reader AUC improvements of 0.0984 for aortic calcification and 0.0885 for dilated aorta, both with p-values below 0.001.

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-read CADe to aid physicians in detecting and localizing chest-radiograph ROIs labeled aortic calcification or dilated aorta, suggestive of aortic atherosclerosis or aortic ectasia; it does not replace the physician or other standard-of-care testing.
  • 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; the FDA packet does not specify a particular institution or facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Concurrent-reading physician aid that generates a DICOM overlay which can be toggled in a PACS viewer while the physician interprets the chest-radiograph study.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Digital chest radiograph studies from adult patients; the FDA comparison identifies digital X-ray input and secure cloud-based processing and delivery, with the output viewed on a PACS system.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
A DICOM Presentation State file for each image in the study. When an ROI is detected, the overlay contains bounding boxes labeled Aortic calcification or Dilated aorta and text suggesting Aortic Atherosclerosis or Aortic Ectasia; when none is detected, the overlay states No Aorta-CAD ROI(s) and contains no bounding boxes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Adult use only. Aorta-CAD is a concurrent-reading aid and does not replace the physician or other diagnostic testing in the standard of care. The ROI labels are findings suggestive of chronic aortic conditions, not a standalone diagnosis; the packet does not establish use outside adult chest radiographs or the described PACS review workflow.
  • 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
K213353
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Aorta and thoracic aortic findings on chest radiographs
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-09-20
  • 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
The FDA comparison describes secure cloud-based processing and delivery of digital chest radiographs to a PACS, and the device returns a DICOM Presentation State overlay that the physician can toggle in the PACS viewer. Specific interface versions, local compatibility, and current commercial data-flow or hosting details are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-cloud
  • 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 Aorta-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
FDA standalone testing assessed 5,000 chest radiograph cases representative of the intended population. Overall sensitivity was 0.910 (95% Wilson CI 0.896-0.922), specificity was 0.896 (0.889-0.902), and ROC AUC was 0.974 (95% bootstrap CI 0.971-0.977). Category results were separate: aortic-calcification sensitivity/specificity 0.922/0.894 and dilated-aorta sensitivity/specificity 0.830/0.897. A fully crossed MRMC reader study used 244 cases and found aided-versus-unaided reader AUC improvements of 0.0984 for aortic calcification and 0.0885 for dilated aorta, both with p-values below 0.001.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Overall standalone: 91.0% (95% Wilson CI 89.6%-92.2%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

FDA K213353 reports separate aortic-calcification and dilated-aorta category endpoints; ROC AUC 0.974 is not accuracy.

Reported specificity
Overall standalone: 89.6% (95% Wilson CI 88.9%-90.2%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

FDA K213353 reports separate aortic-calcification and dilated-aorta category endpoints; ROC AUC 0.974 is not accuracy.

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

Aorta-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 K213353
  • Samplen=5000
  • IndependenceIndependence not established

K213353

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 K213353 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 K213353. 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
25Fields 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

  1. FDA K213353: Aorta-CAD

    U.S. Food and Drug Administration - Published 2022-09-20 - 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. Aorta-CAD model card (K213353)

    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 K213353

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

    Scope: postmarketSafety

Research history

  1. K213353 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 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 K253502

Critical Care Suite with Enteric Tube Positioning AI Algorithm

Ge Medical Systems, LLC

Analyze frontal chest and abdominal X-ray images to detect and localize a nasally or orally inserted enteric tube, its tip and side port if present, and the diaphragm and airways...

Modality
X-ray/Radiography
Anatomy
Chest/lung and abdomen/stomach; enteric tube, tube tip and side port, diaphragm, and airways including carina and left/right bronchi
Decision
2026-04-14
Detection and CADe
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 K250264

SugarBug (1.x)

Bench7, Inc.

Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-11-07
Detection and CADeQuantification and segmentation