Radiology AI Directory

FDA-cleared profile

ClearRead Xray Pneumothorax

Riverain Technologies, Inc.

ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of a pneumothorax 5 mm or larger; it makes case-level output available to a PACS/workstation for worklist prioritization or triage. Identification of cases suspected of containing a pneumothorax is not for diagnostic use beyond notification. ClearRead Xray Pneumothorax is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. The device does not replace review and diagnosis of the Xrays by trained professionals. The device is not intended tobe used with plain film X-ray.

Acute triage and notification
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

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
ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of a pneumothorax 5 mm or larger; it makes case-level output available to a PACS/workstation for worklist prioritization or triage. Identification of cases suspected of containing a pneumothorax is not for diagnostic use beyond notification. ClearRead Xray Pneumothorax is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. The device does not replace review and diagnosis of the Xrays by trained professionals. The device is not intended tobe used with plain film X-ray.
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Clinical-use display mirrors the best exact-submission purpose source because the reviewed FDA packet did not provide a more specific usable abstraction.

Intended users
Radiologist; trained professionals
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Intended-user text reported in the exact-submission ACR model card.

Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Triage or notification support
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
X-ray/Radiography images or data involving Chest/Lung; consult the FDA labeling for exact protocol, series, and quality requirements.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Output and human action
The AI model outputs a case-level triage score indicating the suspected presence or absence of a pneumothorax 5 mm or larger. The output is sent to a PACS/workstation for worklist prioritization or triage notification. No ROI segmentation or localization is provided.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Clinical output reported in the exact-submission ACR model card.

Limitations
Exclusion criteria: Plain film xray. Scanner manufacturers: All
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Limitations and supported-acquisition details reported in the exact-submission ACR model card.

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
K213566
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Anatomy
Chest/Lung
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Anatomy normalized from explicit exact-submission ACR model-card wording.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-03-10
  • 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 exact-submission ACR model card explicitly references DICOM and PACS in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

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
  • 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

PACS and workstation are 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 ClearRead Xray Pneumothorax; 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
Study type: Stand-Alone Performance. Cases: 1138. Sites: 2
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.

Reported sensitivity
95%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

Reported specificity
95%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

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

ClearRead Xray Pneumothorax regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K213566
  • Samplen=1138
  • Sites2
  • IndependenceIndependence not established

K213566

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 K213566 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 K213566. 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.

Automated sources checkedStatus
2026-09-09Last searched
25Fields reviewed
9Source classes checked
0Awaiting 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 and recall packets were prepared and identity matched, but no new clinical or performance claim was promoted in the conservative fallback. Existing exact-submission facts retain their original source status and applicability; candidate literature remains quarantined. Automated exact-name discovery found 0 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 K213566: ClearRead Xray Pneumothorax

    U.S. Food and Drug Administration - Published 2022-03-10 - 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. ClearRead Xray Pneumothorax model card (K213566)

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

    Scope: intendedUsers, careSetting, 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 K213566

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

    Scope: postmarketSafety

Research history

  1. K213566 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    automated sources checked

Alternatives

Related tools to compare

FDA-cleared K243808

Rayvolve PTX-PE

AZmed

Passive study-level worklist triage for suspected pneumothorax and/or pleural effusion on adult PA or AP chest X-rays; it is not a proactive specialist alert.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2025-03-21
Acute triage and notification
FDA-cleared K232410

SmartChest

Milvue

Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22...

Modality
X-ray/Radiography
Anatomy
Chest/lung
Decision
2024-05-10
Acute triage and notification