Devices · AZmed

Rayvolve

AZmed is listed for Rayvolve (K260378). The FDA list gives May 12, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QBS as “Radiological Computer Assisted Detection/Diagnosis Software For Fracture”: 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 information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260378

Official FDA database record

Date of final decision

May 12, 2026

Company on the FDA list

AZmed

Lead panel

Radiology

Primary product code

QBS

openFDA device name for the code

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Device class

2

Regulation number

892.2090

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary