Rayvolve
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Azmed Sas
Identity
- Trade Name
- Rayvolve FDA UDI
- Generic Name
- X-ray image interpretive software FDA UDI
- Device Name
- Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Cloud/VM) FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Cloud/VM) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770018071022 FDA UDI
- 510(k) Number
- FDA Product Code
- QBS FDA 510(k)FDA UDI
- GMDN Term
- X-ray image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2090 FDA 510(k)
- Regulation Number
- 892.2090 FDA 510(k)FDA UDI
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Rayvolve is a Radiological Computer Assisted Detection/Diagnosis Software for Fracture, designed to assist radiologists in identifying and evaluating fractures in X-ray images. It leverages AI algorithms to enhance diagnostic accuracy and efficiency by highlighting potential fracture sites, reducing interpretation variability, and supporting clinical decision-making in musculoskeletal imaging.
The software is supplied as a digital solution for use in radiology departments, hospitals, and imaging centers. It operates on standard medical imaging workstations and requires no physical sterilization or single-use considerations, as it is a reusable, non-invasive digital tool. Compliance is ensured through FDA 510(k) clearance and MDR authorization, with registration numbers and product codes (QBS) confirming regulatory adherence. No MRI safety or physical size constraints apply, as it functions entirely within existing radiology IT infrastructure.
Frequently asked questions
What specific types of X-ray images can the Rayvolve software analyze for fractures, and how does it assist radiologists in their evaluation?
Rayvolve is designed to analyze musculoskeletal X-ray images to assist radiologists in identifying and evaluating fractures. It uses AI algorithms to highlight potential fracture sites, which helps reduce variability in interpretation and supports more accurate clinical decision-making. The software is tailored for use in radiology departments, hospitals, and imaging centers where musculoskeletal imaging is performed.
Is Rayvolve a single-use or reusable tool, and what are the storage requirements for its deployment?
Rayvolve is a reusable digital tool and does not require physical sterilization or single-use considerations. Since it operates entirely within existing radiology IT infrastructure, no special storage conditions apply beyond standard server or workstation requirements. It is supplied as a software solution for integration into medical imaging systems.
How does Rayvolve integrate into existing radiology workflows, and are there any hardware or infrastructure requirements?
Rayvolve is a digital solution that operates on standard medical imaging workstations, meaning it integrates seamlessly into existing radiology IT infrastructure without requiring additional hardware. It does not impose MRI safety constraints or physical size limitations, as it functions purely as software to enhance fracture detection in X-ray images.
What regulatory pathways does Rayvolve follow, and how does this impact its use in clinical settings?
Rayvolve has obtained FDA 510(k) clearance and MDR authorization, confirming its compliance with regulatory standards. These pathways ensure the software meets established safety and effectiveness criteria for radiological computer-assisted detection and diagnosis. Clinicians can rely on its regulatory backing when incorporating it into fracture evaluation workflows.
Does Rayvolve require any specific training or setup beyond standard IT infrastructure, and how does it support radiologists in reducing diagnostic errors?
While Rayvolve operates on standard medical imaging workstations, its implementation may require minimal training to familiarize radiologists with its AI-driven features. The software reduces diagnostic errors by highlighting potential fracture sites and minimizing interpretation variability, thereby supporting more consistent and accurate clinical decision-making in musculoskeletal imaging.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AI Radiology | Rayvolve & Rayscan AI Suite - azmed.co, AZmed SAS: Products, FDA Status & Funding | Physician AI Tools, AZmed SAS: Rayvolve (FDA-cleared AI medical device), AZmed - LinkedIn
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220164 | Class II | Active |
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Manufacturer
- Manufacturer
- Azmed Sas
Sources (3)
- FDA 510(k) K220164 24 fields · synced Sep 18, 2026
- FDA UDI 69eabab5-9842-41d3-9ed7-00a129e9861c 34 fields · synced May 26, 2026
- EUDAMED 1 fields · synced May 19, 2026