Radiology · 510(k) · 2026
Rayvolve
AZmed. Cleared by FDA on 12 May 2026 under submission K260378, product code QBS (radiological computer assisted detection/diagnosis software for fracture). What FDA's record says, in FDA's words.
Device record · K260378
- Device. RayvolveDEVICE
- Company. AZmed (FR)COMPANY
- Decision. 12 May 2026, 510(k), substantially equivalent (traditional review); received 5 February 2026DECISION
- Panel. RadiologyPANEL
- Product code. QBS, Radiological Computer Assisted Detection/Diagnosis Software For FractureCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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 3 - 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 […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QBS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
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