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 and pediatric population (2 years and over). FDA UDI
- Model / Reference
- 4 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 and pediatric population (2 years and over). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770018071084 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, classified under FDA product code QBS. This AI-powered tool is designed to analyze X-ray images of musculoskeletal regions to assist radiologists and emergency physicians in identifying fractures in both adults and children. It operates as a diagnostic aid, enhancing the detection accuracy of bone fractures through automated image analysis.
The device is supplied as software, intended for use in radiology settings where X-ray imaging is performed. It is not described as single-use or reusable but functions as a digital tool requiring compatible imaging systems for operation. No sterility or physical packaging specifications are provided, and MRI safety is not applicable. The software holds FDA clearance under the Traditional 510(k) pathway, with a clearance date of July 17, 2024, and is authorized for use in radiology workflows. No additional regulatory markings or compliance standards are explicitly stated beyond the FDA clearance.
Frequently asked questions
What clinical scenarios is Rayvolve designed to assist with in a radiology setting?
Rayvolve is an AI-powered software tool designed to assist radiologists and emergency physicians in detecting fractures in musculoskeletal X-ray images for both adults and children. It serves as a diagnostic aid to enhance fracture detection accuracy by analyzing X-ray images of bones, helping to streamline workflows in emergency and diagnostic radiology environments.
How is Rayvolve supplied and what type of imaging systems does it require for operation?
Rayvolve is supplied exclusively as software, meaning it does not come in physical packaging like traditional medical devices. To function, it requires integration with compatible X-ray imaging systems used in radiology settings. No physical installation or consumables are involved—only digital compatibility with existing radiology infrastructure.
Is Rayvolve intended for single-use or repeated use across multiple patients, and does it require sterilization?
Rayvolve is a digital software tool and is not designed for single-use or reuse in the traditional sense. Since it operates on a computer system, it does not require sterilization or physical disposal after each use. Instead, it remains functional for ongoing use in radiology workflows as long as the imaging systems it interfaces with remain operational.
What regulatory pathway was followed for FDA clearance of Rayvolve, and what does this mean for its use?
Rayvolve received FDA clearance through the Traditional 510(k) pathway, specifically determined to be *substantially equivalent* to a predicate device. This means the FDA reviewed it against existing software tools for fracture detection and confirmed it meets safety and effectiveness standards for use as a diagnostic aid in radiology. The clearance is specific to its intended use as a computer-assisted detection tool for fractures in X-ray images.
Does Rayvolve have any limitations regarding the types of X-ray images it can analyze?
While the provided data does not specify exact limitations, Rayvolve is designed to analyze X-ray images of musculoskeletal regions to detect fractures. Its functionality is tied to standard X-ray imaging systems used in radiology, so it is intended for use with conventional radiographic images of bones—primarily for adults and children. For precise compatibility, users should verify its integration with their specific imaging equipment.
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: Rayvolve (FDA-cleared AI medical device), AZmed SAS: Products, FDA Status & Funding | Physician AI Tools, Rayvolve | FDA Radiology AI Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240845 | Class II | Active |
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Manufacturer
- Manufacturer
- Azmed Sas
Sources (2)
- FDA 510(k) K240845 24 fields · synced Sep 20, 2026
- FDA UDI e728d7df-9363-4f2b-ab0e-7c33e5aacd14 34 fields · synced May 26, 2026