# K220164: Rayvolve

- Pathway: 510(k) (Traditional)
- Applicant: Azmed Sas
- Decided: Jun 2, 2022 after 133 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: 2 generations back to DEN180005 (2018). 2 ancestors in all.
3 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)
- K193417: FractureDetect (FX), Imagen Technologies, Inc. (2020) Summary page 6.

## Most influential descendants
- K240845: Rayvolve (2024), 2 descendants of its own
- 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 adults only (> 22 years old ). 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 / Frontal, Lateral,Oblique Clavicle / Frontal Elbow / Frontal, Lateral Forearm / Frontal, Lateral Hip / Frontal, Frog Leg Lateral Humerus / Frontal, Lateral Knee / Frontal, Lateral Pelvis / Frontal Shoulder / Frontal, Lateral, Axillary Tibia/fibula / Frontal, Lateral Wrist / Frontal, Lateral, Oblique Hand / Frontal, Lateral Foot / Frontal, Lateral *For the purposes of this table, “Frontal” is considered inclusive of both posteroanterior (PA) and anteroposterior (AP) views. +Definitions of anatomic area of interest and radiographic views are consistent with the American College of Radiology (ACR) standards and guidelines.

Source page: https://510kreport.com/device/K220164
Methodology: https://510kreport.com/methodology