# K260378: Rayvolve

- Pathway: 510(k) (Traditional)
- Applicant: AZmed
- Decided: May 12, 2026 after 96 days
- Product code: QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180005 (2018). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240845: Rayvolve, Azmed Sas (2024) Summary page 7.

## Most influential descendants
- K261378: Rayvolve AZchest (2026), 0 descendants of its own

## Indications for use
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures, joint effusions and dislocations during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for the adult and pediatric population (=2 years). Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. Rayvolve is indicated for use in adult and pediatric populations to help detect fracture, dislocations and joint effusions on osteoarticular X-rays of the following anatomic area of interest/radiographic views: Study type (Anatomic Area of interest) / Radiographic Views* supported for fracture detection: - Ankle / AP, Lateral, Oblique - Clavicle / AP, AP Angulated View - Elbow / AP, Lateral - Forearm / AP, Lateral - Hip / AP, Frog leg lateral - Humerus / AP, Lateral - Knee / AP, Lateral - Pelvis / AP - Shoulder / AP, Lateral, Axillary - Tibia/fibula / AP, Lateral - Wrist / PA, Lateral, Oblique -Hand / PA, Lateral, Oblique -Foot / AP, Lateral, Oblique. -Ribs AP -Spine PA, Lateral Study type (Anatomic Area of interest) / Radiographic Views* supported for dislocation detection: -Shoulder / AP, Lateral, Axillary -Elbow / AP, Lateral -Hand / PA, Lateral, Oblique Study type (Anatomic Area of interest) / Radiographic Views* supported for joint effusion detection: -Elbow / AP, Lateral -Forearm / AP, Lateral -Arm / AP, Lateral *Definitions of anatomic area of interest and radiographic views are consistent withthe ACR-SPR-SSR Practice Parameter for the Performance of Radiography of theExtremities guideline.

Source page: https://510kreport.com/device/K260378
Methodology: https://510kreport.com/methodology