510(k) · Cleared
ClearedRayvolve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Azmed Sas · QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Cleared on Jun 2, 2022 as substantially equivalent to K193417 (Imagen Technologies, Inc., 2020) after a 133-day review. Its family tree reaches back 2 generations to 2018. 3 later devices descend from it.
- Decided
- Jun 2, 2022
- Review
- 133 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180005 (2018). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 1 generation backK193417 FractureDetect (FX)Imagen Technologies, Inc. · 2020
- This deviceK220164 RayvolveAzmed Sas · 2022
- Descendant · cites it directly · 2 of its ownK240845 RayvolveAzmed Sas · 2024
- Descendant · 2 generations on · 1 of its ownK260378 RayvolveAZmed · 2026
- Descendant · 3 generations on · 0 of its ownK261378 Rayvolve AZchestAZmed · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −1 | K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020 | — |
| 0 (this device) | K220164 | Rayvolve | Azmed Sas | 2022 | — |
| +1 | K240845 | Rayvolve | Azmed Sas | 2024 | — |
| +2 | K260378 | Rayvolve | AZmed | 2026 | — |
| +3 | K261378 | Rayvolve AZchest | AZmed | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 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 K260378 Rayvolvescore 15.2 · 4 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 |
|---|---|---|---|
| * | K193417 | FractureDetect (FX)Summary page 6…as follows: Manufacturer Product Name 510K Number Imagen Technologies FractureDetect (FX) K193417 510 k summary Page 4 on 15 4 Device description The me… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240845 | Rayvolve | 2024 | 2 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240845 (Azmed Sas, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K193417.
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. 2022, 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 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 /…
Read the full statement (156 words)
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.
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/K220164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220164: Rayvolve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220164
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026