Radiology AI Directory

FDA-cleared profile

Rayvolve PTX-PE

AZmed

Authorized purpose: 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.

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.

Product overview

Start with the essentials

Authorized purpose: 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.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: 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.

Evidence takeaway

Evidence from the reviewed source record: The FDA-described validation included 1,000 pneumothorax and 1,000 pleural-effusion radiographs. Pneumothorax sensitivity was 0.9379, specificity 0.9178 and AUC 0.9857. Pleural-effusion sensitivity was 0.9134, specificity 0.9448 and AUC 0.9830. Reported processing times were about 19.43 and 19.56 seconds respectively.

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
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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Intended users
Radiologists and other qualified healthcare professionals reviewing adult chest radiographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Care setting and population
Healthcare radiology services using adult PA or AP chest radiography.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Workflow role
Passive study-level triage in PACS/DICOM workflow; it does not annotate the original image and is not a standalone clinical decision.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Required input
Adult PA or AP chest X-rays received as DICOM studies; the FDA-described validation used 1,000 radiographs for pneumothorax and 1,000 for pleural effusion, with balanced positive and negative case groups.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Output and human action
A passive study-level header or secondary-capture result sent to PACS/DICOM node for worklist triage; no markup is placed on the original image.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Limitations
The product is not a proactive specialist alert, does not annotate the original image, and is not intended as a standalone clinical decision or rule-out system.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

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
K243808
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Anatomy
Chest/Lung
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-03-21
  • 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
Study-level result is transmitted through a DICOM node/PACS workflow for passive worklist triage.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Deployment and data flow
Standalone software connected to the radiology DICOM/PACS workflow; exact local hosting and routing terms are not specified in the public summary.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

The reviewed sources do not establish exact-release security controls, retention or assurance documentation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Passive PACS worklist triage

The cleared output is a study-level header or secondary capture sent through a DICOM node/PACS workflow without markup on the original image.

exact submission · checked 2026-09-07
Source

Rayvolve family workflow

AZmed presents Rayvolve as a radiology AI suite intended to fit clinical imaging workflows; the current page does not establish exact hosting, service levels or version for K243808.

product family · checked 2026-09-06
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 FDA-described validation included 1,000 pneumothorax and 1,000 pleural-effusion radiographs. Pneumothorax sensitivity was 0.9379, specificity 0.9178 and AUC 0.9857. Pleural-effusion sensitivity was 0.9134, specificity 0.9448 and AUC 0.9830. Reported processing times were about 19.43 and 19.56 seconds respectively.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Reported sensitivity
0.9379 for pneumothorax; 0.9134 for pleural effusion
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

Separate endpoints and populations; see evidence.metrics.

Reported specificity
0.9178 for pneumothorax; 0.9448 for pleural effusion
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

Separate endpoints and populations; see evidence.metrics.

Pneumothorax sensitivity

0.9379 proportion

  • EndpointSensitivity
  • Population1,000 adult chest radiographs in the FDA pneumothorax validation set
  • Tested versionRayvolve PTX-PE configuration submitted in K243808
Source

Pneumothorax specificity

0.9178 proportion

  • EndpointSpecificity
  • Population1,000 adult chest radiographs in the FDA pneumothorax validation set
  • Tested versionRayvolve PTX-PE configuration submitted in K243808
Source

Pneumothorax AUC

0.9857 area under ROC curve

  • EndpointAUC
  • Population1,000 adult chest radiographs in the FDA pneumothorax validation set
  • Tested versionRayvolve PTX-PE configuration submitted in K243808
Source

Pleural-effusion sensitivity

0.9134 proportion

  • EndpointSensitivity
  • Population1,000 adult chest radiographs in the FDA pleural-effusion validation set
  • Tested versionRayvolve PTX-PE configuration submitted in K243808
Source

Pleural-effusion specificity

0.9448 proportion

  • EndpointSpecificity
  • Population1,000 adult chest radiographs in the FDA pleural-effusion validation set
  • Tested versionRayvolve PTX-PE configuration submitted in K243808
Source

Pleural-effusion AUC

0.983 area under ROC curve

  • EndpointAUC
  • Population1,000 adult chest radiographs in the FDA pleural-effusion validation set
  • Tested versionRayvolve PTX-PE configuration submitted in K243808
Source

Pneumothorax processing time

19.43 seconds

  • EndpointMedian or reported processing time as stated in the FDA summary
  • PopulationFDA pneumothorax validation set
  • Tested versionRayvolve PTX-PE configuration submitted in K243808
Source

Pleural-effusion processing time

19.56 seconds

  • EndpointMedian or reported processing time as stated in the FDA summary
  • PopulationFDA pleural-effusion validation set
  • Tested versionRayvolve PTX-PE configuration submitted in K243808
Source

Rayvolve PTX-PE pneumothorax and pleural-effusion validation

  • DesignRetrospective standalone diagnostic performance validation described in the FDA 510(k) summary
  • PopulationTwo 1,000-radiograph adult chest X-ray sets, one for pneumothorax and one for pleural effusion
  • Scopeexact submission
  • Tested versionRayvolve PTX-PE configuration submitted in K243808
  • Samplen=2000
  • IndependenceSponsor or vendor study

K243808

The two disease endpoints use separate 1,000-study populations; results should not be treated as one pooled disease cohort.

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 2026-09-07

No public price or quote for Rayvolve PTX-PE was reviewed.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-07

Payer policy research was not part of this worker's scope.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

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
2026-09-07Last searched
24Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is not a full-paper review. 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, vendor product page, stored candidate metadata, 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 510(k) K243808: Rayvolve PTX-PE

    U.S. Food and Drug Administration - Accessed 2026-09-07

    Scope: identity, purpose, clinicalUse, modality, anatomy, workflowRole, intendedUsers, careSetting, input, output, limitations, integration, deployment, reportedSensitivity, reportedSpecificity, evidenceMetrics, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Rayvolve PTX-PE model card (K243808)

    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. AI Radiology: Fracture Detection, Chest, Measure, BoneAge

    AZmed - Accessed 2026-09-06

    Scope: productFamilyContext, implementationCapabilities

Research history

  1. K243808 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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