Rayvolve AI Fracture Detection Software

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number03770018071084 UDI-DI	Date11 Oct 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK240845	Date17 Jul 2024Cleared	StatusActive

Official records

AccessGUDID record UDI-DI 03770018071084
FDA 510(k) database 510(k) number K240845

Across registries

2 registries list this device

FDA 510(k) K240845 decided 17 Jul 2024 Active
FDA GUDID UDI-DI 03770018071084 listed 11 Oct 2024 Listed

Timeline

2 dated events

17 Jul 2024 Cleared FDA 510(k) K240845
11 Oct 2024 Listed FDA GUDID 03770018071084

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic name: X-ray image interpretive software
Model / reference: 4

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

Device class: Class II
Regulation: 21 CFR Part 892.2090
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Rayvolve K220164 2 Jun 2022 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K240845

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K240845
		UDI-DI	Size and differences
Rayvolve 4 Azmed Sas	4	03770018071060	—	On the market
Rayvolve 4 Azmed Sas	4	03770018071077	—	On the market
Rayvolve 4 Azmed Sas	4	03770018071084	—	On the market

Similar devices

Other devices filed under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).

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Properties

Lot / batch number
Manufacturing date

Other properties (13, all answered No)