510(k) · Cleared
ClearedRayvolve AZchest
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 Aug 28, 2026 as substantially equivalent to K260378 (AZmed, 2026) after a 123-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Aug 28, 2026
- Review
- 123 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN180005 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 4 generations backK193417 FractureDetect (FX)Imagen Technologies, Inc. · 2020
- 3 generations backK220164 RayvolveAzmed Sas · 2022
- 2 generations backK240845 RayvolveAzmed Sas · 2024
- 1 generation backK260378 RayvolveAZmed · 2026
- This deviceK261378 Rayvolve AZchestAZmed · 2026
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K260378 | Rayvolve Cleared while this submission was under review Summary page 6…Table 2: Device identification 3. Predicate device and reference device Primary Predicate Device Device Name: Rayvolve Manufacturer: AZmed 510(k) Number: K260378 Regulation Number: 21 CFR 892.2090 Product Code: QBS Reference Device Device Name: Critical Care Suite Manufacturer: GE Healthca… | 2026 |
| † | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 1.8 years on median.
- None of the 5 ancestors has a recall.
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 AZchest is a radiological computer-assisted detection and diagnosis (CADe/x) software device that analyzes frontal chest radiographs for the presence of specific targeted pathologies within the Pleura, Mediastinum, and Parenchyma. Rayvolve uses deep learning techniques to detect, identify, and provide diagnostic outputs by labeling Regions of Interest (ROIs). The device highlights ROIs using bounding boxes for Pleural effusion, Consolidation and…
Read the full statement (210 words)
Rayvolve AZchest is a radiological computer-assisted detection and diagnosis (CADe/x) software device that analyzes frontal chest radiographs for the presence of specific targeted pathologies within the Pleura, Mediastinum, and Parenchyma.
Rayvolve uses deep learning techniques to detect, identify, and provide diagnostic outputs by labeling Regions of Interest (ROIs). The device highlights ROIs using bounding boxes for Pleural effusion, Consolidation and increased cardiothoracic ratio (CTR). For Pneumothorax, the device highlights ROIs using bounding boxes or contours to assist in the diagnosis of this condition.
Detection of Pleural effusion, Pneumothorax, and increased CTR is indicated only for chest radiographs acquired in the erect or semi-erect positions. Detection of Consolidation is indicated for chest radiographs acquired in erect, semi-erect, or supine positions.
Rayvolve AZchest is not indicated for the analysis of non-diagnostic images (e.g., due to severe motion artifacts or exposure issues).
Rayvolve AZchest is intended for use as a second-reading aid for radiologists. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
It does not replace the role of radiologists or of other diagnostic testing in the standard of care.
Rayvolve AZchest is for prescription use only and is indicated for adult and pediatric patients (aged 18 years and older) only.
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/K261378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261378: Rayvolve AZchest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261378
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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