Rayvolve

FDA 510(k) K260378 · AZmed

Substantially Equivalent

510(k) numberK260378

Submission

Device name
Rayvolve
Applicant
AZmed
Paris, FR
Received
February 5, 2026
Decision date
May 12, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QBS – Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2090
Specialty
Radiology

A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide…

Other 510(k)s with product code QBS

510(k)DeviceApplicantDecision
K261378Rayvolve AZchestQBS · Traditional AZmed08/28/2026SE
K242171TechCare TraumaQBS · Traditional Milvue01/17/2025SE
K240712icobrain ariaQBS · Traditional Icometrix NV11/07/2024SE
K240845RayvolveQBS · Traditional Azmed Sas07/17/2024SE
K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1…QBS · Traditional Ge Medical Systems, LLC05/25/2023SE
K222176BoneViewQBS · Traditional Gleamer03/02/2023SE
K220164RayvolveQBS · Traditional Azmed Sas06/02/2022SE
K212365BoneViewQBS · Traditional Gleamer03/01/2022SE
K193417FractureDetect (FX)QBS · Traditional Imagen Technologies, Inc.07/30/2020SE

More from Imagen Technologies, Inc.

510(k)DeviceDecision
K261378Rayvolve AZchestQBS · Traditional 08/28/2026SE
K243831Rayvolve LNMYN · Traditional 03/26/2025SE
K243808Rayvolve PTX-PEQFM · Traditional 03/21/2025SE
K240845RayvolveQBS · Traditional 07/17/2024SE
K220164RayvolveQBS · Traditional 06/02/2022SE

Questions and answers

When was Rayvolve cleared by the FDA?

Rayvolve (K260378) received a 510(k) decision of Substantially Equivalent on May 12, 2026, 96 days after the submission was received.

What is the product code of K260378?

The FDA product code is QBS – Radiological Computer Assisted Detection/Diagnosis Software For Fracture, a Class II (moderate risk) device regulated under 21 CFR 892.2090.