# K240845: Rayvolve

- Pathway: 510(k) (Traditional)
- Applicant: Azmed Sas
- Decided: Jul 17, 2024 after 112 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: 3 generations back to DEN180005 (2018). 3 ancestors in all.
2 later devices descend 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)
- K220164: Rayvolve, Azmed Sas (2022) Summary page 6.

## Most influential descendants
- K260378: Rayvolve (2026), 1 descendant of its own
- 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 during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (≥ 2 years). Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. Study type (Anatomic Area of interest) / Radiographic Views* supported: 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. *Definitions of anatomic area of interest and radiographic views are consistent with the ACR-SPR-SSR Practice Parameter for the Performance of Radiography of the Extremities guideline.

Source page: https://510kreport.com/device/K240845
Methodology: https://510kreport.com/methodology