510(k) · Cleared
ClearedAuto Lung Nodule Detection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Electronics Co., Ltd. · MYN Analyzer, Medical Image
Cleared on Aug 31, 2021 as substantially equivalent to P000041 (Riverain Medical Group, 2001) after a 447-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Aug 31, 2021
- Review
- 447 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P000041 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backP000041 Rapidscreen RS-2000Riverain Medical Group · 2001
- This deviceK201560 Auto Lung Nodule DetectionSamsung Electronics Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK243831 Rayvolve LNAZmed · 2025
- Descendant · cites it directly · 0 of its ownK231805 qXR-LNQure.Ai Technologies · 2023
- Descendant · cites it directly · 0 of its ownK223133 VisiRad XRImidex, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −1 | P000041 | Rapidscreen RS-2000 | Riverain Medical Group | 2001 | — |
| 0 (this device) | K201560 | Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. | 2021 | — |
| +1 | K243831 | Rayvolve LN | AZmed | 2025 | — |
| +1 | K231805 | qXR-LN | Qure.Ai Technologies | 2023 | — |
| +1 | K223133 | VisiRad XR | Imidex, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | P000041 | Rapidscreen RS-2000Summary page 5…510(k) Premarket Notification - Traditional C. Classification: Medical image analyzer D. Product Code: MYN E. 510(k) Number or PMA Number: P000041 F. Decision Date: July 12, 2001 Predicate Device… | 2001 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 10 to 30 mm in size. It is designed to aid the physician to review the PA chest radiographs of adults as a second reader and be used as part of S-Station, which is operation software installed on Samsung Digital X-ray Imaging systems. Auto Lung Nodule Detection cannot be used on the patients who have lung lesions other than abnormal nodules.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201560: Auto Lung Nodule Detection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201560
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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