Rayvolve Fracture Detection Software

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number03770018071022 UDI-DI	Date18 Mar 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK220164	Date2 Jun 2022Cleared	StatusActive
European Union	CE/MDR EUDAMED	Number—	Date—	StatusActive

Official records

EUDAMED public site
AccessGUDID record UDI-DI 03770018071022
FDA 510(k) database 510(k) number K220164

Across registries

3 registries list this device

FDA 510(k) K220164 decided 2 Jun 2022 Active
EUDAMED Active
FDA GUDID UDI-DI 03770018071022 listed 18 Mar 2024 Listed

Timeline

2 dated events

2 Jun 2022 Cleared FDA 510(k) K220164
18 Mar 2024 Listed FDA GUDID 03770018071022

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name: X-ray image interpretive software
Model / reference: 2

Primary DI / UDI-DI: 03770018071022
510(k) Number: K220164
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

FractureDetect (FX) K193417 30 Jul 2020 FDA record · FDA summary

Cited by

Rayvolve K240845 17 Jul 2024 FDA record · FDA summary

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

Overview

AI-generated summary, 18 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, 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.

Devices cleared under K220164

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 K220164
		UDI-DI	Size and differences
Rayvolve 2 Azmed Sas	2	03770018071022	—	On the market
Rayvolve 2 Azmed Sas	2	03770018071008	—	On the market
Rayvolve 2 Azmed Sas	2	03770018071015	—	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)