510(k) · Cleared
ClearedRayvolve LN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AZmed · MYN Analyzer, Medical Image
Cleared on Mar 26, 2025 as substantially equivalent to K201560 (Samsung Electronics Co., Ltd., 2021) after a 103-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Mar 26, 2025
- Review
- 103 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P000041 (2001). No later device cites it as a predicate yet.
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 MYN? 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 MYN device
- #1 K210365 Second Opinionscore 29.9 · 1 generation · 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 |
|---|---|---|---|
| * | K201560 | Auto Lung Nodule DetectionSummary page 7…Commercial Name 510K Number Samsung Auto Lung Nodule Auto Lung Nodule Electronics Co., Detection Detection K201560 Ltd. 4. Device description The medical device is called Rayvolve LN. Rayvolve LN is one of the verticals of the Rayvolve produ… | 2021 |
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 24 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K201560.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
What is it indicated for?
Rayvolve LN is a computer-aided detection software device to assist radiologists to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30mm size. It is designed to aid radiologists in reviewing the frontal (AP/PA) chest radiographs of patients of 18 years of age or older acquired on digital radiographic systems as a second reader and be used with any DICOM Node server. Rayvolve LN provides adjunctive information only and is not a substitute for the original chest radiographic image.
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/K243831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243831: Rayvolve LN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243831
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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