FDA-cleared profile
AZmed SAS
Assists radiologists and emergency physicians in detecting fractures on DICOM musculoskeletal radiographs for adults and children aged 2 years or older, limited to the FDA-listed anatomic areas and standard views (ankle, clavicle, elbow, forearm, hip, humerus, knee, pelvis, shoulder, tibia/fibula, wrist, hand, and foot); it is an aided-diagnosis device and does not operate autonomously.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Specific interface versions, routing, viewer behavior, and local compatibility remain acceptance-test items.
The FDA summary does not establish current hosting region, retention, security controls, uptime, or commercial configuration.
The FDA comparison table contains a privacy characteristic, but the reviewed sources do not establish the current commercial security architecture, retention, access controls, audit, or incident-response terms.
The FDA packet says instructions for use are transmitted and used to train users; current onboarding, competency, and support commitments were not established.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation remain to be qualified.
The exact FDA packet describes interaction with existing DICOM Node servers such as PACS and clinical-grade viewers, with the original image followed by the processed image containing fracture prediction and localization.
exact submission · checked 2026-09-07Test representative identifiers, routing, image ordering, annotation toggles, and failure handling locally.
The FDA packet describes on-premise and cloud operation connected to the radiology center local network and DICOM Node server.
exact submission · checked 2026-09-07Current hosting, PHI flow, retention, and service commitments are not established.
AZmed's current Rayvolve page describes local PACS/workflow integration in a radiology customer testimonial and presents Rayvolve as an AI second opinion for fracture detection.
product family · checked 2026-09-07Vendor page and testimonial; it does not establish a specific connector, PACS version, SLA, or local deployment result.
The NIHR/NICE early value assessment table describes Rayvolve in the assessed NHS context as using DICOM radiographs and integrating into existing hospital radiology workflows through Wellbeing's AI Connect gateway. That assessment lists Rayvolve as adult-only for its evaluated context, whereas the exact K240845 FDA indication includes pediatric patients aged 2 years or older.
product family · checked 2026-09-07Historical assessment context; do not use it to narrow or expand the exact FDA indication without the K240845 packet.
NICE HTG739 conditionally recommends Rayvolve for use in NHS urgent care while evidence is generated and calls for local disagreement protocols plus monitoring of accuracy, software failures, downstream referrals, treatment changes, implementation cost, subgroups, and postmarket surveillance.
product family · checked 2026-09-08English NHS health-technology guidance; not exact K240845 pricing, reimbursement, or US adoption evidence.
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.
The 3,016-case results are standalone pediatric testing; do not merge them with predicate adult clinical-reader results.
Endpoint is image-level standalone sensitivity for the pediatric dataset; the structured metric records the paired specificity and AUC separately.
Endpoint is image-level standalone specificity for the pediatric dataset.
0.9611 proportion
0.8597 proportion
0.9399 ROC-AUC
K240845
The FDA packet states that no clinical study was conducted in support of K240845; this standalone assessment supported inclusion of the pediatric population.
K240845
Baseline ACR summary retained; FDA packet details above control endpoint and pediatric scope.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No current exact-product price or contract terms were established from the reviewed public sources. The NICE assessment used a notional cost input, not a vendor quote.
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
NICE HTG739 conditionally recommends Rayvolve for NHS use during a two-year evidence-generation period, subject to evidence-generation agreements and appropriate regulatory and DTAC approval; this is not a reimbursement determination.
NICE guidance for the NHS in England · England · Effective 2025-01-14NICE's exploratory model uses GBP 1 per scan and says actual software, implementation, and postmarket costs are uncertain. This is not a vendor quote or US coverage evidence.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The stored evidence-candidates metadata and identifier lists were screened in order. This was metadata screening, not a full paper or ClinicalTrials.gov record review; no candidate abstract or full text is promoted here. The current discovery snapshot contains 9 PubMed and 1 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, health technology assessment, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: regulatoryIdentity, purpose, modality, anatomy
Scope: regulatoryIdentity, modalityContext
Scope: purpose, modality, intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
Scope: productFamily, clinicalWorkflow, PACS, implementationCapabilities
Scope: productFamily, implementationContext, populationContext
Scope: conditionalAdoption, economics, evidenceGaps, implementationCapabilities
Regulatory record
510(k)
Research record
human reviewed
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