510(k) · Cleared
ClearedRayvolve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AZmed · QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Cleared on May 12, 2026 as substantially equivalent to K240845 (Azmed Sas, 2024) after a 96-day review. Its family tree reaches back 4 generations to 2018. 1 later device descends from it.
- Decided
- May 12, 2026
- Review
- 96 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN180005 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 3 generations backK193417 FractureDetect (FX)Imagen Technologies, Inc. · 2020
- 2 generations backK220164 RayvolveAzmed Sas · 2022
- 1 generation backK240845 RayvolveAzmed Sas · 2024
- This deviceK260378 RayvolveAZmed · 2026
- Descendant · cites it directly · 0 of its ownK261378 Rayvolve AZchestAZmed · 2026
Most influential descendants
Showing 1 of 1 · See all- K261378Rayvolve AZchestAZmed · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −3 | K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020 | — |
| −2 | K220164 | Rayvolve | Azmed Sas | 2022 | — |
| −1 | K240845 | Rayvolve | Azmed Sas | 2024 | — |
| 0 (this device) | K260378 | Rayvolve | AZmed | 2026 | — |
| +1 | K261378 | Rayvolve AZchest | AZmed | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QBS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QBS device
- #1 K261378 Rayvolve AZchestscore 13.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K240845 | RayvolveSummary page 7…dentified as follows: Manufacturer Product Name 510K Number AZmed Rayvolve K240845 Table 3: Predicate device 4. Device description The medical device is called Rayvolve. It is a st… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261378 | Rayvolve AZchest | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K261378 (AZmed, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QBS devicesQBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QBS
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QBS
123in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QBS
No recall names QBS since 2007.
Adverse event reports per year · QBS
No MAUDE report names QBS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 123 | 0 | — |
What is it indicated for?
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…
Read the full statement (251 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260378: Rayvolve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260378
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026