# Rayvolve

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/rayvolve-qbs-k240845>
- Manufacturer: [Azmed Sas](https://devicerts.com/manufacturers/azmed-sas) (France)
- Device class: Class II (US FDA)
- FDA product code: QBS
- GMDN: X-ray image interpretive software (63386)

## Overview

*AI-generated summary, 2026-09-20. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 03770018071084 · listed 2024-10-11 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K240845 · decision 2024-07-17 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: X-ray image interpretive software [FDA GUDID (AccessGUDID)]
- Model / reference: 4 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 03770018071084 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K240845 [FDA 510(k), FDA GUDID (AccessGUDID)]
- FDA product code: QBS [FDA 510(k), FDA GUDID (AccessGUDID)]
- GMDN term: X-ray image interpretive software (63386) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 892.2090 [FDA 510(k), FDA GUDID (AccessGUDID)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Rayvolve, Azmed Sas. deviCERTS medical device catalogue. https://devicerts.com/devices/rayvolve-qbs-k240845 (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-06
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/rayvolve-qbs-k240845.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/rayvolve-qbs-k240845
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.