Radiology AI Directory

FDA-cleared profile

DeepTek CXR Analyzer v1.0

DeepTek Medical Imaging Pvt Ltd

Authorized purpose: Concurrent CADe support for identifying, categorizing, and highlighting suspicious regions of interest in the Lungs, Pleura, Cardiac, and Hardware categories on chest radiographs for radiologist review.

Cardiac imagingDetection 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 support for identifying, categorizing, and highlighting suspicious regions of interest in the Lungs, Pleura, Cardiac, and Hardware categories on chest radiographs for radiologist review.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Concurrent CADe support for identifying, categorizing, and highlighting suspicious regions of interest in the Lungs, Pleura, Cardiac, and Hardware categories on chest radiographs for radiologist review.

Evidence takeaway

Evidence from the reviewed source record: FDA packet: standalone testing used 3,000 scans (2,000 NIH and 1,000 Segmed) with three U.S. board-certified radiologists establishing majority ground truth. Image-level standalone sensitivity/specificity/AUROC by category were Lungs 0.903/0.937/0.971, Pleura 0.924/0.897/0.964, Cardiac 0.924/0.930/0.978, Hardware 0.947/0.947/0.980, and aggregate 0.926/0.933/0.974. ROI-level wAFROC-FOM was aggregate 0.920. The 300-image, 24-reader MRMC study from 13 U.S. hospitals found aggregate aided wAFROC-FOM 0.893 (95% CI 0.871-0.914) versus unaided 0.821 (0.791-0.852), p<0.0001; reader sensitivity/specificity were separate aided/unaided endpoints.

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 support for identifying, categorizing, and highlighting suspicious regions of interest in the Lungs, Pleura, Cardiac, and Hardware categories on chest radiographs for radiologist review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Radiologists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Radiologist chest-radiograph reading workflow; the clinical reader study used 13 U.S. hospitals, but the FDA packet does not define all facility types.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Concurrent-reader CADe detection, category classification, localization, and highlighting of suspicious chest-radiograph ROIs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Adult frontal chest radiographs in DICOM format from adults and transitional adolescents aged 18 to under 22 years who are treated like adults.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
A secondary-capture DICOM image containing the original radiograph, manufacturer/product/version information, color-coded bounding boxes for suspected Lungs, Pleura, Cardiac, or Hardware ROIs, or a 'No Suspicious ROI(s) Detected' message when no boxes are present; workflow errors are logged.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The device is an adjunct and not the primary interpretation; radiologists must review the annotated and original unannotated images. It does not make treatment recommendations or provide a diagnosis and is not designed to detect conditions outside the four listed categories; the labeled population is adults and transitional adolescents treated as adults.
  • 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
K231001
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Chest: lungs, pleura, cardiac structures, and hardware
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-10-05
  • 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 packet describes configurable PACS connectivity using AE Title, IP address, listener and sender ports, DICOM chest-radiograph input from the configured PACS, and secondary-capture DICOM output returned to that PACS; it does not establish universal PACS/RIS/EHR compatibility.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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 2026-09-09

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

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 DeepTek CXR Analyzer v1.0; 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
FDA packet: standalone testing used 3,000 scans (2,000 NIH and 1,000 Segmed) with three U.S. board-certified radiologists establishing majority ground truth. Image-level standalone sensitivity/specificity/AUROC by category were Lungs 0.903/0.937/0.971, Pleura 0.924/0.897/0.964, Cardiac 0.924/0.930/0.978, Hardware 0.947/0.947/0.980, and aggregate 0.926/0.933/0.974. ROI-level wAFROC-FOM was aggregate 0.920. The 300-image, 24-reader MRMC study from 13 U.S. hospitals found aggregate aided wAFROC-FOM 0.893 (95% CI 0.871-0.914) versus unaided 0.821 (0.791-0.852), p<0.0001; reader sensitivity/specificity were separate aided/unaided endpoints.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Image-level standalone at the recommended operating threshold: Lungs 0.903 (95% CI 0.887-0.914); Pleura 0.924 (0.902-0.932); Cardiac 0.924 (0.890-0.952); Hardware 0.947 (0.936-0.955); Aggregate 0.926 (0.917-0.933).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

These are category- and aggregate-labeled standalone image-level endpoints; AUROC, wAFROC-FOM, and MRMC reader endpoints remain distinct.

Reported specificity
Image-level standalone at the recommended operating threshold: Lungs 0.937 (95% CI 0.927-0.948); Pleura 0.897 (0.879-0.911); Cardiac 0.930 (0.925-0.941); Hardware 0.947 (0.939-0.954); Aggregate 0.933 (0.925-0.938).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

These are category- and aggregate-labeled standalone image-level endpoints; aided/unaided reader specificity is a separate MRMC endpoint.

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

DeepTek CXR analyzer v1.0 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 K231001
  • Samplen=3000
  • IndependenceIndependence not established

K231001

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 K231001 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 K231001. 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
2026-09-20Last searched
26Fields 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 K231001: DeepTek CXR Analyzer v1.0

    U.S. Food and Drug Administration - Published 2023-10-05 - 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. DeepTek CXR analyzer v1.0 model card (K231001)

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

    Scope: intendedUsers, careSetting, output, limitations, 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 K231001

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

    Scope: postmarketSafety

Research history

  1. K231001 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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