Radiology AI Directory

FDA-cleared profile

Rayvolve

AZmed SAS

Computer-assisted detection and diagnosis to assist radiologists and emergency physicians in detecting fractures on specified adult musculoskeletal radiographs; indicated for adults at least 22 years old.

MSK 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.

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
Computer-assisted detection and diagnosis to assist radiologists and emergency physicians in detecting fractures on specified adult musculoskeletal radiographs; indicated for adults at least 22 years old.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Radiologists and emergency physicians
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Musculoskeletal radiograph review in a medical imaging/PACS workflow; the FDA packet does not establish a specific commercial facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Aided fracture detection and localization during radiograph review, integrated with a PACS workflow; Rayvolve does not operate autonomously and the physician remains responsible for interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM radiographs from adults at least 22 years old, limited to the FDA-listed anatomic regions and views: ankle, clavicle, elbow, forearm, hip, humerus, knee, pelvis, shoulder, tibia/fibula, wrist, hand, and foot, with frontal, lateral, oblique, frog-leg-lateral, or axillary views as specified.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
A prediction of the potential presence or absence of fracture with localized image annotations or bounding-box information for fracture review in the PACS workflow; the original image remains available for physician interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Rayvolve is an aided-diagnosis device and does not operate autonomously or replace medical doctors. The labeled population is adults at least 22 years old and the labeled input is limited to the listed musculoskeletal anatomic regions, radiographic views, and DICOM radiographs. Results require radiologist or emergency-physician review and are not established for other populations, regions, views, or workflows.
  • 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
K220164
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Musculoskeletal system: ankle, clavicle, elbow, forearm, hip, humerus, knee, pelvis, shoulder, tibia/fibula, wrist, hand, and foot
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-06-02
  • 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
Rayvolve is described as standalone software intended to work with PACS servers; when remotely connected to a medical-center PACS it directly interacts with DICOM files to output fracture predictions. The comparison describes secure local DICOM processing and delivery with PACS image annotations that can be toggled, but no specific interface version or current local compatibility is established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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 2026-09-08

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.

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 Rayvolve; 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 evaluated 2,626 radiographs from 851 patients at four US sites across all indicated study types and views. Standalone sensitivity was 0.98763 (95% Wilson CI 0.97559-0.99421), specificity was 0.88558 (0.87119-0.89882), and ROC AUC was 0.98607 (95% bootstrap CI 0.98104-0.99058). The MRMC reader study used 24 clinical readers and 186 cases; reader AUC improved from 0.84602 unaided to 0.89327 aided, reader sensitivity from 0.86561 to 0.9554, and reader specificity from 0.82645 to 0.83116. The reader endpoints are separate from the standalone model results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Overall standalone: 98.763% (95% Wilson CI 97.559%-99.421%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

FDA K220164 reports ROC AUC 0.98607 separately; reader-aided results are not standalone device endpoints.

Reported specificity
Overall standalone: 88.558% (95% Wilson CI 87.119%-89.882%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

FDA K220164 reports ROC AUC 0.98607 separately; reader-aided results are not standalone device endpoints.

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

Rayvolve 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 K220164
  • Samplen=851
  • Sites4
  • IndependenceIndependence not established

K220164

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 K220164 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 K220164. 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
2026-09-08Last searched
25Fields reviewed
9Source classes checked
9Awaiting review PubMed leads
1Awaiting 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 scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 9 PubMed and 1 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 K220164: Rayvolve

    U.S. Food and Drug Administration - Published 2022-06-02 - 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. Rayvolve model card (K220164)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, 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 K220164

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

    Scope: postmarketSafety

Research history

  1. K220164 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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